Clinical Complaint Specialist Masimo CorporationClinical Complaint SpecialistIrvine, CA$80,000–$100,000 / yearThis role applies clinical expertise to evaluate complaint events, assess potential patient impact, determine regulatory reportability, support investigations, and ensure accurate complaint documentation. Collaborate with Quality, Regulatory Affairs, Medical Affairs, Clinical Affairs, Engineering, Manufacturing, and other cross-functional teams to support complaint investigations and resolution activities.
Senior Manager, Quality Engineering BiVACORSenior Manager, Quality EngineeringHuntington Beach, CaliforniaAs Senior Manager, Quality Engineering, you will serve as a principal leader within the BiVACOR quality organization, responsible for architecting and directing quality engineering functions across the full product lifecycle of the Total Artificial Heart (TAH) system, one of the most technically advanced implantable devices in development today. You will not only lead the QE team in verification and validation, manufacturing process quality, supplier controls, and regulatory compliance — you will define the strategic direction of quality engineering programs, drive enterprise-level QMS maturity, and serve as a senior executive liaison across quality, engineering, manufacturing, regulatory affairs, and clinical functions.
NewManager, IT ERP - SAP Manufacturing Envista DentistryManager, IT ERP - SAP ManufacturingBrea, California$164,300–$190,000 / yearThis role provides functional governance rather than hands-on configuration, directing the Managed Service Provider (MSP), reviewing and approving functional designs and validation artifacts, setting priorities, and holding delivery partners accountable for quality, compliance, and service performance. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes.
Microbiologist Integrated Resources, IncMicrobiologistIrwindale, CaliforniaContractorMinimum a 4 year degree in the sciences (preferential in Microbiology/Engineering/Chemistry/Biochemistry) with 3-5 years' work experience with a proven track record in Equipment Validation and general laboratory techniques within the medical device and/or pharmaceutical industry or master's degree in engineering and 2-3 years of experience in the field or in a related area. Following SOPs and special test designs; analyzes test data and completes required documentation, initiates and manages QA test method improvements, equipment, and process validations.
Account Executive TransPerfectAccount ExecutiveLos Angeles, CaliforniaAre you looking for a role where you can exhibit the utmost integrity, deliver the highest quality, provide outstanding service, act as if you own it, work with a sense of urgency, treat everyone with respect, operate as a cohesive team, celebrate diversity, be financially responsible, and achieve results? Develop and execute account plans that identify expansion opportunities across service lines, including clinical trial translation, COA/linguistic validation, regulatory labeling, eTMF/clinical technology, and AI-enabled translation workflows.
Account Executive (Business Development OR Account Management) TransPerfectAccount Executive (Business Development OR Account Management)Los Angeles, CaliforniaAre you looking for a role where you can exhibit the utmost integrity, deliver the highest quality, provide outstanding service, act as if you own it, work with a sense of urgency, treat everyone with respect, operate as a cohesive team, celebrate diversity, be financially responsible, and achieve results? Develop and execute account plans that identify expansion opportunities across service lines, including clinical trial translation, COA/linguistic validation, regulatory labeling, eTMF/clinical technology, and AI-enabled translation workflows.
Sr Quality Engineer LanceSoft IncSr Quality EngineerNorthridge, CA$50–$55 / hourThe Quality Engineer will partner closely with Quality, Manufacturing, Regulatory Affairs, R&D, Operations, Supplier Quality, and Customer Service teams to investigate quality issues, drive corrective and preventive actions (CAPA), maintain risk management documentation, and support post-market surveillance activities. Bachelor’s degree in Engineering, Quality, Biomedical Engineering, Mechanical Engineering, Industrial Engineering, Chemical Engineering, or related technical discipline.
NewSr. Mechanical Design Engineer Nihon Kohden Orange MedSr. Mechanical Design EngineerSanta Ana, CA$120,000–$150,000 / yearIndependently develop and maintain mechanical engineering documentation throughout the product lifecycle, including design specifications, drawings, engineering analyses, design reviews, change orders, and Design History File (DHF) records, in accordance with established design controls, FDA requirements, and applicable quality system procedures. Collaborate with Quality Assurance, Regulatory Affairs, Manufacturing, suppliers, and other cross-functional teams to ensure mechanical designs and supporting documentation meet applicable regulatory and quality requirements and support regulatory submissions, including 510(k) submissions where applicable.
NewSr Director, Clinical Sciences Tarsus PharmaceuticalsSr Director, Clinical SciencesIrvine, CaliforniaRemoteLeadership Competencies - This role requires mastery of the Tarsus Leadership Competencies for Leading Teams, including: Empowering Others - Fosters empowerment by aligning authority with accountability, developing leaders’ decision-making capability, and creating systems that support performance and growth. The Sr Director, Clinical Sciences will lead Clinical Science (Eyecare) function, accountable for the scientific integrity, quality, and strategic impact of all eyecare clinical studies from early development through late-stage registration and lifecycle management.
Senior Manager, Clinical and PV Quality Assurance (Inspection Readiness and Management) Arrowhead PharmaceuticalsSenior Manager, Clinical and PV Quality Assurance (Inspection Readiness and Management)Los Angeles, CA$145,000–$170,000 / yearPartner with executive leadership and cross-functional stakeholders to maintain a continuous state of inspection readiness, ensure effective execution of regulatory inspections and audits, foster high-quality regulatory interactions, and drive timely responses to inspection and audit observations, CAPAs, and continuous improvement initiatives. Lead the Inspection Readiness and Management Program, serving as the primary Inspection Lead responsible for planning, hosting, facilitating, and directing regulatory inspections conducted by the FDA (BIMO), MHRA, PMDA, EMA, and other global Health Authorities, including Pharmacovigilance post-marketing inspections.
Design Assurance Engineer II Envista DentistryDesign Assurance Engineer IIPomona, CaliforniaEnvista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. Working cross-functionally with R&D, Manufacturing, Regulatory Affairs, Quality, and Operations, this role contributes to product risk management, test method development, data analysis, reliability evaluations, investigations, CAPA activities, and process validation.
Senior Quality Engineer I RxSightSenior Quality Engineer IAliso Viejo, CA$105,000–$120,000 / yearThe Senior Quality Engineer I will be responsible for establishing documentation control and approval workflows to support manufacturing and testing for processes, test methods, test results, batch records, etc. for manufacturing and collaborate with Product Development, Manufacturing, and other cross-functional teams to ensure product quality and regulatory compliance. The Senior Quality Engineer I will support all RxSight products and will be expected to apply knowledge of process engineering, risk management, and quality engineering techniques to innovate and improve quality system processes while simultaneously ensuring conformance to applicable regulatory requirements.
Quality Systems And Compliance Manager Teledyne TechnologiesQuality Systems And Compliance ManagerIndustry, CA$96,600–$128,800 / yearThe Quality Systems and Compliance Manager is responsible for developing, implementing, maintaining, and continually improving the Quality Management System (QMS) in accordance with ISO 9001:2015, ISO 13485:2016, applicable regulatory requirements, and EU Medical Device Regulation (MDR) 2017/745. This position provides leadership and oversight for quality assurance, regulatory compliance, risk management, supplier quality management, internal audits, corrective and preventive actions, complaint handling, post-market surveillance activities, and management review processes.
Quality Systems and Compliance Manager Teledyne TechnologiesQuality Systems and Compliance ManagerCity of Industry, CaliforniaThe Quality Systems and Compliance Manager is responsible for developing, implementing, maintaining, and continually improving the Quality Management System (QMS) in accordance with ISO 9001:2015, ISO 13485:2016, applicable regulatory requirements, and EU Medical Device Regulation (MDR) 2017/745. This position provides leadership and oversight for quality assurance, regulatory compliance, risk management, supplier quality management, internal audits, corrective and preventive actions, complaint handling, post-market surveillance activities, and management review processes.
Amazon Compliance Specialist Kitsch LLCAmazon Compliance SpecialistLos Angeles, CARemoteFull timeEstablished in 2010, with a business plan no longer than a paragraph, Kitsch has grown from door to door sales to selling products in over 27 countries across 20,000 retail locations worldwide. Develop and maintain a master labeling matrix by SKU and marketplace covering required warnings, symbols, barcodes, language, and regulatory marks.
Director, Technical Management iHerbDirector, Technical ManagementIrvine, CaliforniaGenerally requires a minimum of 12 years of experience in product development, regulatory affairs, or quality management within dietary supplements, nutraceuticals, OTC, or a related consumer health category. The Director, Technical Management is responsible for leading the formulation, regulatory compliance, quality assurance, product safety, and packaging/labeling functions for iHerb’s Owned Brands.
Quality Assurance Coordinator - Hybrid University of California, IrvineQuality Assurance Coordinator - HybridOrange, CaliforniaFull timeResponsibilities: The Quality Assurance Coordinator conducts and assists with internal quality assurance monitoring and auditing activities for assigned clinical research studies at all participating sites under the CFCCC for the overall review of regulatory, subject management, data compliance, and Investigational Drug Service/Pharmacy research activities under the direction of the Quality Assurance Officer. *Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.
Engineer, Combination Devices (Technical Lead) Arrowhead PharmaceuticalsEngineer, Combination Devices (Technical Lead)Los Angeles, CA$120,000–$145,000 / yearThis individual will partner closely with cross-functional teams, including Product Development, Packaging, Manufacturing, Clinical Development, Supply Chain, Commercial, Quality, and Regulatory Affairs, to ensure combination products are developed in accordance with applicable regulatory requirements and meet patient needs. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
NewMedicare Compliance Project Manager SCAN Health PlanMedicare Compliance Project ManagerLong Beach, CaliforniaHowever, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. Regulatory Audit Leadership & Coordination – Lead coordination of regulatory audits (CMS, federal, and state) from intake through close, including tracking requests, managing deliverables, and facilitating communication across business areas to ensure timely and accurate responses.
VP, Clinical Development Tarsus PharmaceuticalsVP, Clinical DevelopmentIrvine, CaliforniaRemoteLeadership Competencies - This role requires mastery of the Tarsus Leadership Competencies for Leading Teams, including: Empowering Others - Fosters empowerment by aligning authority with accountability, developing leaders’ decision-making capability, and creating systems that support performance and growth. This position will oversee Clinical Sciences, Clinical Operations, Biostats/Data Mgmt and will partner cross-functionally with Regulatory Affairs, Translational Sciences, Medical Affairs, Commercial, Innovation lab, Finance and Legal to drive efficient and scientifically rigorous clinical work.