CQA Vendor Oversight and Quality Assurance Lead (US) CSL BehringCQA Vendor Oversight and Quality Assurance Lead (US)King of Prussia, PAWe use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.
GLP Vendor Oversight and Quality Assurance Lead CSL BehringGLP Vendor Oversight and Quality Assurance LeadKing of Prussia, PAWe use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.
Auditor - GVP CSL BehringAuditor - GVPKing of Prussia, PAWe use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. Trend Analysis: Identify non-compliance trends and systematic risks within the PV discipline, communicating these findings to line management and functional leads to support PV system health and protect the integrity of the PSMF documenting it.
Auditor - GLP CSL BehringAuditor - GLPKing of Prussia, PATrend Analysis: Identify non-compliance trends and systematic risks within the Non-clinical (GRLP/GLP/GCLP) discipline, communicating these findings to line management and clinical functional leads to ensure trial robustness. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
Auditor - GCP CSL BehringAuditor - GCPKing of Prussia, PAWe use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. Trend Analysis: Identify non-compliance trends and systematic risks within the Clinical (GCP) discipline, communicating these findings to line management and clinical functional leads to ensure trial robustness.
QRM Support Manager - National Tax Quality Assurance (NTQA), Quality Risk Deloitte Touche Tohmatsu LtdQRM Support Manager - National Tax Quality Assurance (NTQA), Quality RiskPA$93,000–$191,000 / yearOur team supports client-facing teams in how they approach the marketplace, develop service offerings, evaluate and onboard prospective clients, contract for services, deliver quality client service, and fulfill post-engagement and other recurring obligations. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities.
Quality Assurance - Quality Inspector/Technician Viant Medical LLCQuality Assurance - Quality Inspector/TechnicianCollegeville, PAManagement Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements. This position will work to maintain elements of Quality Management Systems (QMS) in accordance with ISO 13485 and FDA 21 CFR 820 requirements as well as company protocols.
Senior QA Automation Engineer (SDET) BC ForwardSenior QA Automation Engineer (SDET)Pennington, NJ$60–$60.40 / hourFull timeThe ideal candidate will have strong experience in test automation, API automation, CI/CD integration, and Agile SDLC and a proven ability to design and execute manual and automated tests that meet functional, non-functional, and compliance requirements while driving high-quality releases. With delivery centers and offices across North America and India, we take pride in building long-term relationships and delivering excellence through innovation, collaboration, and integrity.
Digital Assurance & Transparency - IT Audit Senior Manager PricewaterhouseCoopers LLPDigital Assurance & Transparency - IT Audit Senior ManagerPA$119,000–$299,930 / yearIn digital assurance at PwC, you will focus on providing assurance services over clients'' digital environment, including processes and controls, cyber security measures, data and AI systems, and their associated governance, to help organisations and their stakeholders build trust in their technology while complying with relevant regulations. Preferred field(s) of study in: Accounting, Accounting & Technology, Finance, Economics and Finance, Economics and Finance & Technology, Management Information Systems, Business Administration/Management, Engineering, Computer and Information Science, Computer and Information Science & Accounting, Mathematics, Economics.
Digital Assurance & Transparency - IT Audit Manager PricewaterhouseCoopers LLPDigital Assurance & Transparency - IT Audit ManagerPA$99,000–$252,450 / yearAs a Manager you will supervise, develop, and coach teams, manage client service accounts, and drive assigned client engagement workstreams by supervising teams and independently solving and analyzing complex problems to develop quality deliverables. In digital assurance at PwC, you will focus on providing assurance services over clients digital environment, including processes and controls, cyber security measures, data and AI systems, and their associated governance, to help organisations and their stakeholders build trust in their technology while complying with relevant regulations.
Senior Specialist, Quality Assurance Validation Bristol-Myers Squibb CoSenior Specialist, Quality Assurance ValidationNew Brunswick, NJ$78,980–$95,708 / yearBased on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
QA PROLIM Global CorporationQAPrinceton, NJThis role combines hands-on test execution with advisory and collaboration skills, making it a crucial part of the ServiceNow teams efforts to maintain the stability, functionality, and efficiency of ServiceNow implementations within an organization. Collaborating with Technical Consultants, Business Process Consultants, and Project Managers to support both internal development and customer UAT.
Executive Director, Microbiology Quality Sterility Assurance Bristol-Myers Squibb CoExecutive Director, Microbiology Quality Sterility AssurancePrinceton, NJ$260,860–$316,097 / yearThis position brings critical expertise in sterility assurance, microbiological controls, and contamination control strategy across BMS's internal and external commercial and PD manufacturing sites - spanning pharmaceutical, biopharmaceutical, cell therapy and radiopharmaceuticals. Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
CQA Vendor Oversight and Quality Assurance Lead (US) CSL Behring LLCCQA Vendor Oversight and Quality Assurance Lead (US)King of Prussia, PAWe use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.
GLP Vendor Oversight and Quality Assurance Lead CSL Behring LLCGLP Vendor Oversight and Quality Assurance LeadKing of Prussia, PAWe use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.
Lead, QA Strategy Johnson & JohnsonLead, QA StrategyTitusville, NJAll Job Posting Locations: Beerse, Antwerp, Belgium, Latina, Italy, Little Island, Cork, Ireland, Malvern, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America, Zug, Switzerland. Lead QRM and QRA execution, produce risk metrics, and drive continuous improvement through lessons learned and preventive actions aligned with enterprise risk frameworks.
Submarine Systems Quality Assurance Specialist NoblisSubmarine Systems Quality Assurance SpecialistPhiladelphia, Pennsylvania$90,700–$124,750 / yearFull timeBachelor of Science (BS) degree in Engineering and a minimum of 3 years of relevant professional experience, OR High School diploma and 9 years of progressive submarine-related experience, such as shipyard, maintenance activity, IMA, RMC, or fleet support roles supporting U.S. Navy submarines. Experience developing, reviewing, auditing, or validating Objective Quality Evidence (OQE) in accordance with Navy and DoD quality assurance requirements , including documentation packages supporting material certification, testing, inspections, and acceptance for Fleet delivery.
Quality Assurance Specialist Amgen IncQuality Assurance SpecialistAllentown, PAIn addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients.
QA Auditing Reviewer Amneal Pharmaceuticals IncQA Auditing ReviewerPiscataway, NJ$23–$32 / hourDescription: This QA Auditing Reviewer role is responsible for thoroughly auditing production records, determining batch disposition (Release, Hold, Reject), and executing those decisions in systems like JDE while ensuring held or rejected batches are properly controlled and stored. Essential Functions: Thoroughly audit all production records (work order #1 and #2 for commercial and exhibit batches) and determine batch disposition (Release, Hold, Reject).
QA Document & Artwork Coordinator TreeHouse Foods IncQA Document & Artwork CoordinatorMoorestown, NJ$25–$32.95 / hourThis position plays a key role in maintaining quality, food safety, supplier, and packaging documentation while supporting packaging artwork proofing, regulatory compliance, customer communications, and cross-functional Quality Assurance and R&D initiatives. An employee's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, seniority, geographic location, performance, shift, travel requirements, sales or revenue-based metrics and business or organizational needs.
Director - Design Quality Assurance - Tissue Technologies Integra LifeSciencesDirector - Design Quality Assurance - Tissue TechnologiesPrinceton, NJ$166,750–$228,850 / yearThese activities include the development, implementation, and monitoring of quality programs and policies that ensure the development, manufacture, and distribution of medical devices in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO 13485, the Canadian Medical Device Regulations (CMDR), the EU Medical Device Regulation, Japanese Pharmaceutical Affairs Law, and other applicable global regulatory agencies. The Director, Design Quality Assurance (DQA) - Tissue Technologies division has the primary responsibility to ensure the delivery of high-quality design history files (DHF) and Risk management files (RMF) that are compliant with applicable global regulations.
Senior Manager, Deviation Management - Quality Assurance Madrigal Pharmaceuticals IncSenior Manager, Deviation Management - Quality AssuranceConshohocken, PA$147,600–$180,400 / yearPlease know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality.
Quality Assurance Reviewer Globus MedicalQuality Assurance ReviewerAudubon, PennsylvaniaEnsures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role. Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
NewQA Inspector AmcorQA InspectorNew Jersey4.1.3 Must be able to speak, write and read effectively in order to understand packing labels, safety posters, and other forms of written communication. 3.8 Identify and control non-conforming material as per company procedures, conduct back tracking for non-confirming product to assure all suspected ware has been isolated.
NewSupplier Quality Assurance Engineer (PSP) Veeco Instruments IncSupplier Quality Assurance Engineer (PSP)PAFrom the smartphones in our pockets that access the world's collective knowledge, to the cloud-based services where all that information lives, to high-speed wireless communication and computing power needed to drive artificial intelligence, augmented and virtual reality, gaming and so much more, our technology is all around us. Preferred certifications include one or more of the following: ASQ Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE), Certified Supplier Quality Professional (CSQP), Quality Auditor (CQA), ISO Lead Auditor, or equivalent.
NewQuality Assurance Specialist Amneal Pharmaceuticals IncQuality Assurance SpecialistPiscataway, NJThis role partners closely with production, engineering, suppliers, and product development teams to drive compliance, root cause analysis, process validation, and the implementation of quality systems using tools such as Six Sigma, SPC, PFMEA, and process capability studies. Works with product development, Tech services and production during product transfer to ensure quality deliverables (PFMEA, Control Plans, Inspection Plan, Inspection Equipment and Tooling) are in place.
Regional Quality Assurance Manager APG National GroupRegional Quality Assurance ManagerPhiladelphia, PA$90,000–$100,000 / yearOur portfolio of brands includes Oldcastle APG, Oldcastle Infrastructure, Belgard® hardscape, Echelon® Masonry, RDI® railing, Catalyst™ Fence Solutions, Sakrete® packaged concrete, Amerimix® mortar, Pebble Technology International® pool finishes, and Techniseal® sands and sealant technologies. We're a trusted and strategic partner to engineers, contractors, distributors, specifiers, retailers, and homeowners alike as the manufacturer of precast concrete, polymer concrete, and plastic infrastructure products.
Quality Assurance Manager The PNC Financial Services Group IncQuality Assurance ManagerPhiladelphia, PA$65,000–$121,000 / yearAnalytical Thinking, Controls Testing, Corporate Governance, Leadership, QA Methodologies, Quality Assurance (QA), Quality Assurance Testing, Quality Support, Software Testing, Test Case Development, Test Planning, Usability Testing. In addition, PNC generally provides the following paid time off, depending on your eligibility: maternity and/or parental leave; up to 11 paid holidays each year; 9 occasional absence days each year, unless otherwise required by law; between 15 to 25 vacation days each year, depending on career level; and years of service.
Registered Nurse - Quality Assurance,Home Health Hospice KeystoneCareRegistered Nurse - Quality Assurance,Home Health HospiceMedia, PA$85,000–$95,000Your primary responsibilities will include creating, implementing, and maintaining educational curricula focused on both home health and hospice care protocols, ensuring that all nurses stay abreast of the latest practices and regulatory requirements. You will also oversee the quality assurance processes, evaluating performance and care outcomes, identifying areas for improvement, and developing strategies to enhance patient care.
QA Engineer - Onsite - Warminster, PA FujifilmQA Engineer - Onsite - Warminster, PAWarminster, PABy offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials, we partner with the brightest minds in biotech and pharma to tackle the world’s biggest health challenges. Drive continuous improvement within the organization, particularly concerning non-conformance CAPA (corrective and Preventative Actions), audit observations, complaints, and other quality datasets.
Quality Assurance Analyst (SDET, Automated, Java, P Apidel TechnologiesQuality Assurance Analyst (SDET, Automated, Java, PPhiladelphia, PAContractorEstablish milestones and monitor adherence to plans and schedules, identify delivery risks, and obtain/drive mitigation strategies and solutions. Deliver quality process training to technical staff and acts as an internal quality consultant to advise or influence business or technical partners.
Quality Engineer II - Design & Reliability Assurance Integra LifeSciences Holdings CorpQuality Engineer II - Design & Reliability AssurancePlainsboro, NJ$71,300–$97,750 / yearThe Design Quality Assurance Engineer (DQA) is responsible for the efficient and compliant support of New Product Development (NPD) and Sustaining/Remediation project(s) of varying scope and complexity in the Tissue Technology (TT) division, as well as risk management work for new and existing products. Writing & coordinating efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs to support development and sustaining/remediation projects.
Staff Quality Engineer, Design & Reliability Assurance Integra LifeSciences Holdings CorpStaff Quality Engineer, Design & Reliability AssurancePrinceton, NJ$109,250–$149,500 / yearThe Staff Design Quality Assurance Engineer (DQA) is a subject matter expert responsible for the efficient and compliant support of New Product Development (NPD) and Sustaining/Remediation project(s) of varying scope and complexity in the Tissue Technology (TT) division, as well as risk management work for new and existing products. Writing & coordinating efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs to support development and sustaining/remediation projects.
Senior Engineer II - Quality Design & Reliability Assurance Integra LifeSciences Holdings CorpSenior Engineer II - Quality Design & Reliability AssurancePrinceton, NJ$82,000–$113,000 / year5 years of experience of working within a medical device or other regulated industry with knowledge of Risk Management (ISO 14971 2019), EU MDR, MDD (Medical Device Directive), IEC 62366, ISO 13485 (Quality Management Systems), FDA QSR and cGMP. Fulfill design control requirements compliant: software specifications, detailed design files, design verification and validation test plans, risk management, DHF, protocols, and reports in accordance with company procedures, FDA and ISO guidelines.
Sr Quality Engineer, Design Assurance Integra LifeSciences Holdings CorpSr Quality Engineer, Design AssurancePlainsboro, NJ$81,650–$112,700 / yearThe Design Quality Assurance Engineer (DQA) is responsible for the efficient and compliant support of New Product Development (NPD) and Sustaining/Remediation project(s) of varying scope and complexity in the Tissue Technology (TT) division, as well as risk management work for new and existing products. Writing & coordinating efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs to support development and sustaining/remediation projects.
Senior Quality Assurance Automation Manager USCS External PositionsSenior Quality Assurance Automation ManagerCamden, New JerseyThe Senior Quality Assurance Automation Manager will lead and grow an existing QA team while building a cross-functional quality program spanning software development, data analytics, and customer technology. Every day, our systems coordinate the storage and movement of food at national scale across a network of state-of-the-art distribution centers, including multiple highly automated warehouse facilities.
NewData Architect / Quality Assurance Engineer City of Philadelphia PAData Architect / Quality Assurance EngineerPhiladelphia, PASome examples of OIT's commitment to serving the public through the effective and innovative integration of City open data include: https://Atlas.phila.govhttps://property.phila.govhttps://Openmaps.phila.govhttps://streetsmartphl.phila.gov/www.phila.gov/solarmapwww.phila.gov/stressmapEssential Experience savings of 10% to 40% on your educational expenses, extending not only to City employees but in some cases, spouse and dependents too!*The successful candidate must be a city of Philadelphia resident within six months of hireEffective May 22, 2023, vaccinations are no longer required for new employees that work in non-medical, non-emergency or patient facing positions with the City of Philadelphia.
Quality Assurance Inspector II - 2nd Shift Amneal Pharmaceuticals IncQuality Assurance Inspector II - 2nd ShiftPiscataway, NJ$21–$27 / hourDescription: To monitor and ensure all incoming raw materials, packaging components and returned goods are sampled, inspected and tested (where applicable) for the purpose of determining compliance with established specifications. Preparation of labeling components/outserts inspection reports; quarantine and release labels and maintaining incoming components log and corresponding inventory cards.
QA Stability Specialist Amneal Pharmaceuticals IncQA Stability SpecialistNJ$60,000–$85,000 / yearAt the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.
QA Specialist / Copyeditor Octane LearningQA Specialist / CopyeditorPrinceton, New JerseyYou will work on a variety of projects with several different styles of training, primarily interactive media such as eLearning, instructor-led courses/workshops, videos, and print resources. We advise on learning strategies and create the right experiences, including online study, virtual, in-person and hybrid workshops, reference resources, sales/corporate training events, and more.
NewJunior QA Engineer - Manual and Automation Ace IT CareersJunior QA Engineer - Manual and AutomationPhiladelphia, PA$70,720–$95,680Selected candidates may work on functional testing, defect management, API validation, database testing, regression testing, and automation activities based on project requirements. Ace IT Careers is recruiting candidates for Junior QA Engineer opportunities involving both manual software testing and test automation.
QA Technician StratAcuity Staffing Partners IncQA TechnicianPennsauken, NJIn terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts.
Quality Assurance Analyst Computer Aid IncQuality Assurance AnalystTrenton, NJ$45–$52 / hourWe are looking for a Quality Assurance Tester to support quality assurance efforts for enterprise systems, with a primary focus on Salesforce-based applications and data modernization initiatives. Create functional and non-functional test cases and acceptance criteria for Salesforce Lightning components, custom objects, and automated Flows.
QA Inspector Amcor PlcQA InspectorCranbury, NJ4.1.3 Must be able to speak, write and read effectively in order to understand packing labels, safety posters, and other forms of written communication. 3.8 Identify and control non-conforming material as per company procedures, conduct back tracking for non-confirming product to assure all suspected ware has been isolated.
QA Tech (3rd Shift) Simmons Foods IncQA Tech (3rd Shift)Quakertown, PAAccepts responsibility to quickly identify any areas that lack cohesiveness, bringing them to the attention of the team leader and working with the team in a supportive manner to resolve issues and actively look for ways, and reinforce actions needed, to achieve synergy possible within the larger organization. Integrity and Trust: Is widely trusted; is seen as a direct, truthful individual; can present the unvarnished truth in an appropriate and helpful manner; keeps confidences; admits mistakes; doesn't' misrepresent him/herself for personal gain.
Project Leader - QA Holman Enterprises, Inc.Project Leader - QANew JerseyRemoteCreate and maintain meaningful quality metrics: based on the product or project, determine how QA will be measured, how performance excellence will be achieved and recommend changes to improve quality across the life cycle. Coordinate the testing for software releases: make sure that the planned items can be tested in the time frame allotted.
Quality Assurance Supervisor, 3rd Shift Kenvue Brands LLCQuality Assurance Supervisor, 3rd ShiftFort Washington, PAFull timeThe position will interact with other departments including Manufacturing, Packaging, Quality Laboratories, Quality Systems, Validation, Engineering, Maintenance and other departments as it relates to site Quality Assurance responsibilities. Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® and BAND-AID® that you already know and love.
Senior Quality Assurance Automation Manager United States Cold Storage IncSenior Quality Assurance Automation ManagerCamden, NJPart timeThe Senior Quality Assurance Automation Manager will lead and grow an existing QA team while building a cross-functional quality program spanning software development, data analytics, and customer technology. Every day, our systems coordinate the storage and movement of food at national scale across a network of state-of-the-art distribution centers, including multiple highly automated warehouse facilities.
Quality Assurance Engineer II Integra LifeSciences Holdings CorpQuality Assurance Engineer IIPlainsboro, NJ$71,300–$97,750 / yearThe Quality Assurance Engineer II will monitor, prioritize and track the timely closure of NCs and CAPAs for the Plainsboro Plant facility, participate in problem solving teams, and participate from a Quality Engineering & Quality Systems and Plant perspective on the launching of new or improved products/processes. Facilitates the development, implementation and monitoring of quality programs and policies that ensure that the development, manufacture and distribution of medical products is in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO 9001, ISO 13485, the Medical Device Directive, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies.
Senior Director, Quality Assurance Commercial & Compliance Rocket Pharmaceuticals IncSenior Director, Quality Assurance Commercial & ComplianceCranbury, NJ$232,000–$277,000 / yearThis includes the following specific areas: training; electronic Quality Management System (eQMS) oversight; supplier management (including the qualification of vendors, supplier change notifications, quality technical agreement management); Commercial Product processes including Product Complaints, Annual Reports, Product Recall. Broad knowledge and experience with quality assurance and quality systems, quality operations, regulatory compliance and understanding of current US/EU regulatory requirements and trends for manufacturing of Drug Substance, Drug Product and advance therapies (i.e., Cell Gene Therapy).