Lead Auditor, Quality Compliance Integra LifeSciences Holdings Corp.Lead Auditor, Quality ComplianceBraintree, MA$109,250–$149,500 / yearThe Lead Auditor, Quality Compliance will form part of the Corporate Audit team and will lead, coordinate and perform corporate audits of the Quality Management System (QMS) as part of Integra LifeScience's quality internal audit program across more than 15 design, manufacturing, and distribution facilities and a diverse portfolio of leading medical devices. The incumbent will possess extensive GMP audit experience and practical skills including: the ability to write objective technical audit reports, evaluate and make objective judgments on technical issues arising during the audit, utilize multi-cultural sensitivity while driving audits forward consistently and on time, as well as project and time management.
NewTranslation Quality Assurance Specialist (Bilingual Portuguese) Framingham Public SchoolsTranslation Quality Assurance Specialist (Bilingual Portuguese)Framingham, MAThe requirements listed below represent the knowledge, skills, and abilities required: Linguistic & Editing Expertise: High-level proofreading, editing, and machine-translation post-editing skills; exceptional grasp of grammar, syntax, and cultural nuances in English, and Portuguese. This role utilizes district-approved AI-powered translation software to initiate translations and performs meticulous proofreading, editing, and post-editing to guarantee absolute accuracy, cultural consistency, and regulatory compliance.
Manager of Quality, Infrastructure Engineering Massachusetts Bay Transportation AuthorityManager of Quality, Infrastructure EngineeringBoston, MABachelors degree in civil, Mechanical, Electrical, and Industrial Engineering, or a related field from an accredited institution with 5 or more years of engineering experience in the following industry: transportation, signals & communications, capital asset management, facilities management and power or a related industry. Have a satisfactory work record for the two (2) years immediately prior to the closing date of this posting (unless if current student or recent graduate), including overall employment, job performance, discipline, and safety records (infractions and/or offenses occurring after the closing of the posting and before the filling of a vacancy may preclude a candidate from consideration for selection).
Sr. Engineer, Quality Allografts LeMaitre Vascular IncSr. Engineer, Quality AllograftsBurlington, MABachelors' degree in either Biology, Microbiology, Chemistry, Chemical Engineering, Mechanical Engineering, or Biomedical Engineering required. Applicants with disabilities may contact LeMaitre HR coordinators via telephone, fax, e-mail, and other means to request and arrange for accommodations.
Quality Assurance Specialist Nova Biomedical CorpQuality Assurance SpecialistBillerica, MA$77,000–$86,000 / yearThis role works cross-functionally to maintain an inspection-ready QMS, ensure compliance with regulatory and quality requirements, support implementation of external requirements, and drive continuous improvement initiatives that enhance overall quality system performance and operational effectiveness. With headquarters in Norwood and Waltham, Massachusetts, and a global team of nearly 2,000 employees, were building a collaborative, empowered culture grounded in shared values: Customer Centricity, Ingenuity, Ownership & Accountability, Collaboration, and Integrity.
NewManager, Quality Engineering ImprivataManager, Quality EngineeringWaltham, MA$177,000–$180,000 / year40% telecommuting permitted in U.S. Requires up to 10% travel throughout the U.S. Minimum Qualifications : Must have a Bachelor’s degree in Engineering, Computer Science, or closely related field and 3 years of experience in Quality Control Engineering / Quality Assurance, or a substantially similar position, including the mobile applications for iOS and Android, white box and black box testing, testing applications on Windows, MacOS, iOS, Android and Linux, working in Agile environment, and testing in and managing virtual environments including VMware and Citrix. Position Duties : Manage a team of Quality Engineers primarily tasked with verifying the quality of new feature development, maintenance, and integration with existing platforms through manual and automated testing.
Senior Associate, Quality Assurance Ocular Therapeutix IncSenior Associate, Quality AssuranceBedford, MA$109,000–$121,000 / yearPosition Summary: The Senior Associate, QA will work in collaboration with all departments within Ocular, to provide the necessary Quality Assurance (QA) oversight for the production of Drug Products including support of end-to-end operations from technology transfer and clinical production all the way through commercialization. Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX.
Head of Quality (VP/SVP) TScan Therapeutics IncHead of Quality (VP/SVP)Waltham, MAReporting directly to the Chief Executive Officer, the Head of Quality will serve as a key member of the senior leadership team and will provide executive oversight of all Quality functions, including Quality Assurance (QA), Quality Control (QC), Quality Systems, Validation, Supplier Quality, GMP Compliance, and GxP Quality oversight. Beyond functional leadership, the Head of Quality will serve as an enterprise leader, partnering with executive colleagues to shape corporate strategy, assess organizational risk, enable operational excellence, and ensure quality is integrated into every stage of product development and manufacturing.
Associate Director, Shift Quality Operations Vertex PharmaceuticalsAssociate Director, Shift Quality OperationsBoston, MassachusettsThe position partners closely with Manufacturing, Quality Assurance, Quality Control, MSAT, Engineering, Validation, and Supply Chain to support batch execution, deviation management, investigations, line clearance, contamination control, and continuous improvement. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
Enterprise Data Quality Solutions Lead, Assistant Vice President State StreetEnterprise Data Quality Solutions Lead, Assistant Vice PresidentQuincy, MassachusettsThe successful candidate will play a key role in strengthening enterprise capabilities for data quality management, controls, measurement and reporting, exception and issue management, and BCBS 239-aligned risk data aggregation and reporting outcomes using the Collibra Platform and related technologies. Partner with Business Data Owners, Data Stewards, Data Governance Leads, and Technology teams to implement practical data quality measurement, monitoring, and governance capabilities for measuring data quality, including accuracy, completeness, timeliness, where applicable.
Associate Director, Shift Quality Operations (Onsite) Vertex Pharmaceuticals IncAssociate Director, Shift Quality Operations (Onsite)Boston, MA$153,900–$230,900 / yearThe position partners closely with Manufacturing, Quality Assurance, Quality Control, MSAT, Engineering, Validation, and Supply Chain to support batch execution, deviation management, investigations, line clearance, contamination control, and continuous improvement. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
Principal Associate I, Plant Quality Assurance - 2ND SHIFT ReplimunePrincipal Associate I, Plant Quality Assurance - 2ND SHIFTFramingham, MassachusettsThe Principal Associate I/II, Plant Quality Assurance (PQA) reports to the Associate Director, Quality Assurance and is responsible for on-going Quality oversight to ensure real time quality oversight for Drug Substance, Drug Product, and all other production and QC testing activities according to current good manufacturing practices (cGMP), good documentation practices (GDP) and other applicable regulations. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response.
Associate Quality Engineer Globus Medical Inc.Associate Quality EngineerMethuen, MAPosition Summary: The Associate Quality Engineer will be responsible for achieving the highest quality level of manufacturing quality and quality system performance while ensuring compliance with all company policies and procedures and maintaining compliance with US FDA and international medical device regulations and ISO 13485 quality system requirements. Conduct thorough review of documentation, including but not limited to Document Change Orders (DCOs), engineering drawings, specifications, risk management files, and Verification & Validation (V&V) protocols and reports.
NewQuality Engineer III Mercury Systems IncQuality Engineer IIIHudson, NHExperience with systems such as Product Lifecycle Management software (Agile or similar), ERP system (Oracle or similar), Manufacturing Execution System (Factory Logix or similar), and issue and project tracking software (Jira, Confluence, or similar). This position will focus on delivering quality product that meets customer requirements, identifying opportunities for yield improvement, process improvement, and product cost-reduction methods.
Quality Systems Specialist I Cirtec Medical CorpQuality Systems Specialist ILowell, MA$70,000–$80,000 / yearOur expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems. Must Have: Associates of Science Degree in Manufacturing, Engineering, or Technical Field, or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred).
NewAssociate Director, Analytical Quality by Design and Platform Analytical Method Lifecycle Takeda Pharmaceutical Co LtdAssociate Director, Analytical Quality by Design and Platform Analytical Method LifecycleLexington, MA$154,400–$242,550 / yearPOSITION OBJECTIVES: The Associate Director, Analytical Quality by Design and Platform Analytical Method Life Cycle plays a critical role in implementation of Analytical Quality by Design principles across Analytical Development to improve method robustness, analytical transfers, lifecycle management, and regulatory readiness. Serve as a technical and strategic lead for analytical method lifecycle practices, including risk assessments, method development expectations, validation/verification strategy, analytical transfer readiness, and continued method performance monitoring to ensure execution excellence across a diverse and dynamic global development portfolio.
Senior Associate, Quality Assurance Replimune Group, Inc.Senior Associate, Quality AssuranceFramingham, MA$106,000–$137,000 / yearThe RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. Support the oversight of Replimune GMP compliance and Quality systems: change control, deviation, and corrective and preventive action (CAPA) systems including support of thorough root cause analysis investigations related to quality issues.
Manager, Regulatory/Quality Systems BlockHiresManager, Regulatory/Quality SystemsNashua, New HampshireLead the development of SOPs and work instructions and associated quality tools to improve product quality and to increase work efficiency Identifying opportunities for improvement and developing processes to ensure regulatory compliance and process robustness. 8+ years quality and regulatory experience; 3+ years in a leadership role in a multiple or large site (600+ employees and associated revenue/customer base).
Regional Quality Manager, Southwest (Remote - Travel Required) SOLV Energy LLCRegional Quality Manager, Southwest (Remote - Travel Required)MARemote$116,812–$146,016 / yearIn addition, candidate introductions or resumes can only be submitted to our internal talent acquisition recruiting team if a signed vendor agreement is already on file and the third-party recruiter or agency has received formal instructions from our internal talent acquisition team to submit candidates for a particular job posting. Train and support: Provide direct training and guidance to project teams on quality assurance and control practices, SOLV Energy's Quality SOP's, SWI's, MOP's and reference guides, ensuring that all team members understand and follow established procedures.
Lead Product Quality Engineer, Industrials VulcanFormsLead Product Quality Engineer, IndustrialsNewburyport, MassachusettsThis role goes beyond individual task execution to shape how quality is built into the program from the outset, mentor and develop other quality engineers supporting the program, and represent quality engineering in cross-functional product development & ongoing production initiatives. Independently investigate complex product non-conformances (NCRs), lead material review boards (MRBs), and drive the execution of Corrective and Preventive Actions (CAPAs) to eliminate systemic failure modes.