Post-Market Quality Lead: CAPA & Regulatory Champion
BD Mexico
A leading medical device company in California is hiring for a role focused on post-market quality processes. This position requires extensive experience in Quality Assurance and risk management, particularly with medical devices, and involves ensuring compliance with regulatory standards, managing CAPA, and collaborating across departments. Ideal candidates will have a Bachelor’s Degree in a related field, strong analytical skills, and experience in FDA communications. #J-18808-Ljbffr BD Mexico
$175k - $215k
...Deramiocel (CAP-1002), our lead cell therapy in late-... ...most. The Director, Quality Assurance & Quality... ...company objectives and regulatory standards Develop,... ...conformances, deviations, and CAPA (Corrective and... ...ICH Q9 principles Champion a culture of quality throughout...QualityRegulatoryWork at office- ...Consultant (GxP) to support and enhance Quality Systems at a clinical-stage biotech facility... ...EDMS, and GxP compliance, while ensuring regulatory alignment and operational efficiency.... ...processes including Change Control, Deviations, CAPA, Training, and Document Control. •...QualityRegulatoryLong term contract
$270k - $300k
...Executive Director of GMP Quality Assurance (QA) to serve... ...for developing, leading, and executing the global... ...deviations, investigations, CAPAs, change control,... ...GMP internal audits and regulatory inspections Provide... ...including launch readiness and post-approval operations...QualityRegulatory$43.27 - $52.88 per hour
...Quality Systems Specialist III The Quality Systems Specialist III is responsible for assisting... ...for at least one of the following: CAPA process tracking, trending of approved... ...of personnel to ensure compliance with regulatory requirements and written procedures by...QualityRegulatoryHourly payTemporary workWork at office$100k - $120k
...About the role: The Quality Assurance (QA) Specialist is responsible for supporting... ...maintain quality systems that meet applicable regulatory standards such as ISO 9001, GAMP 5, EU... ...documentation, managing deviations, CAPAs, and change controls, and ensuring that...QualityRegulatoryLocal areaFlexible hours$70k - $82k
...is Deramiocel (CAP-1002), our lead cell therapy in late-stage... ...seeking an individual to join our Quality Compliance department. This... ...Track and verify effectiveness of CAPAs (Corrective and Preventive... ...activities and host/liaise during regulatory inspections (e.g., FDA, EMA,...QualityRegulatory$40.92 - $46.04 per hour
...hosts customer and regulatory audits, assist in... ...knowledgeable of the Quality Management System.... ...: Leads customer and internal... ...deviation reports and CAPAs related to regulatory... ...accordance with posted schedule].... ...policies and programs, marketing approach, and workplace...QualityRegulatoryFull timeFlexible hours$83k - $125k
...The primary role of a Junior Design Quality Engineer ensures new and sustaining products... ...meet quality and safety standards, regulatory requirements, and user needs to... ...Copilot and ChatGPT required Experience leading/supporting CAPAs, NCRs and Issue Impact Assessments...QualityRegulatoryTemporary workWork experience placementFlexible hours- ...Director, Quality Engineering page is loaded## Director... ...: Full timeposted on: Posted Yesterdayjob requisition... ...innovation can lead to better lives. Our work... ...safety, and sustained regulatory compliance.As the enterprise... ...and Preventive Action (CAPA) culture across the organization...QualityRegulatoryContract workWorldwide
$92k - $100k
...Job Description MPF Federal seeks a Quality Assurance Supervisor to support the Naval... ...Management System, ensures compliance to regulatory standards, and makes continuous improvements... ...corrective and preventative actions (CAPA) are implemented effectively. · Provides...QualityRegulatoryContract workLocal area- ...Description Job Description The Quality Systems Engineer plays a... ...in compliance with applicable regulatory requirements (e.g., ISO13485:20... .... This role is responsible for leading and managing Corrective and Preventive Actions (CAPAs), Internal and External Audits,...QualityRegulatory
$26.2 - $34 per hour
...Quality Assurance Coordinator Revvity is a developer and provider of end-to-end solutions... ..., risk management, design control, CAPA, document and change control, training, batch... ...administrative support for external audits (regulatory or customer) and Internal Audits....QualityRegulatoryFull timeWork experience placementWork at officeLocal area- ...Contract / Consultant Department: Quality Assurance Reports To: Site... ...contracted role, you will lead the enhancement and... ...You will ensure compliance with regulatory requirements while supporting... ...as Change Control, Deviation, CAPA, Training, and Document Control...QualityRegulatoryContract workWork at officeLocal area
$100k - $130k
Overview We are looking for an experienced Quality Manager to ensure that our products and... ...of corrective and preventive actions (CAPA) Lead and participate in internal audits and... ...with industry best practices and regulatory requirements Requirements Minimum Bachelor...QualityRegulatory$75k - $90k
...Growth Marketing Lead (Demand Systems) We Inspect | Remote Most marketing jobs are about running channels. This one isn’t. We Inspect... ...firm specializing in mold inspection and indoor air quality. We help families and health practitioners identify environmental...QualityRemote work- ...Data Integrity Consultant A leading biotechnology company is... ...environment. This role will provide Quality oversight of computerized... ..., and compliance with global regulatory standards to support cell and... ...inspections (FDA/EMA) and managing CAPA and risk mitigation efforts....QualityRegulatoryLocal areaShift work
$130k - $180k
...places to work. About the Role Orchard is looking for a Growth Marketing Lead to own our paid digital strategy. You will manage an 8-figure... ...and an understanding of how to optimize for full-funnel quality, not just cost-per-lead Demonstrated ability to use AI to create...QualityFull timeFreelanceWork at officeRemote work2 days per week- ...complaints conform to regulatory requirements and company... ...internal audit and CAPA actions as they relate... ...Partners with other quality professionals to address... ...Leadership commitments: How we lead ourselves and our work... ...complaint handling / post-market surveillance / medical...QualityRegulatoryWorldwide
$75k - $83k
...Sr. Quality Assurance Specialist Location: San Diego, CA | Employment... ...products meet the highest regulatory and quality standards while... ...audits, change control, CAPA management, complaint handling... ...Manufacturing, Development, Marketing, and Corporate Quality on customer...QualityRegulatoryFull timeContract workCasual workWork at officeWorldwideAfternoon shift$133k - $166k
...from rigorous innovation can lead to better lives. Our work continues... ...: The Senior Manager, Quality Assurance GCP will support the... ...oversee assigned audits, support regulatory inspections, and support the... ...trackers and trend audit findings / CAPAs / resolution processes across...QualityRegulatoryLocal area- ...Manager of UX Design leads a high-performing team... ...digital platforms. Champion a customer-first mindset... ...Product, Engineering, Marketing, Data, and Operations... ...Design Execution & Quality Oversee end-to-end... .... Familiarity with regulatory or compliance-driven UX...QualityRegulatory
$130 - $160 per hour
...within our communities. As a leading network of advanced clinical... ...patient-centered, high-quality clinical trials. The site conducts... ...and women's health studies. Championing Diversity in Clinical Trials... ...with protocol requirements, regulatory standards, and ethical...QualityRegulatoryFull time$87k - $145k
...future ambition is to become a leading consumer health technology... ...heart of Dexcom's products. Our quality engineering team plays a... ...and guide the application of regulatory requirements, shape equipment... ...process validation architecture, CAPA strategy, process controls,...QualityRegulatoryWorldwide$210k - $270k
...Deramiocel (CAP-1002), our lead cell therapy in... ...Senior Director, Quality Assurance & Quality... ...ensure sustained regulatory compliance, inspection... ...launch, and post‑approval lifecycle... ...Deviations/Investigations/CAPA, Training and... ...distribution oversight, post‑market quality monitoring,...QualityRegulatoryWork at office- ...Contract / Consultant Department: Quality Assurance Reports To: Site... ..., and compliant with global regulatory expectations. You will act as... ...Program Leadership Lead the deployment, enhancement, and... ...: Change Control, Deviations, CAPA, Document Control, and Training...QualityRegulatoryContract workWork at officeLocal area
- ...Processing. This commitment drives dedication to quality and accurate case handling, for overall... ...the varying medical philosophies of regulatory bodies worldwide and the idiosyncrasies... ...Accountable for multiple tasks including CAPA, ICSR reconciliation, database interfaces...QualityRegulatoryWorldwide
- ...pharmaceutical company based in San Diego is seeking a Director, Quality Engineering to lead strategic initiatives in GMP compliance and quality risk... ...The ideal candidate will possess extensive experience in regulatory environments and a strong background in quality...QualityRegulatory
- ...dignity, rekindle hope, and champion resilience during some of life... ...progress adhering to facility and regulatory standards Engage in care... ...communication and teamwork qualities Proficient in digital... ...it's after surgery or amidst post-stroke healing. This role...QualityRegulatoryLocal areaImmediate startFlexible hours
$85.12k - $95.76k
...adherence to applicable regulatory requirements and... ...preparation, execution support, CAPA coordination, and... ...tracking, and supports Quality Management System (QMS)... ...and documentation. Lead and support customer audits... ...policies and programs, marketing approach, and workplace...QualityRegulatoryFull timeFlexible hoursWeekend work- ...Manufacturing Operations to lead the transformation and scaling... ...production, planning, supply chain, quality, and engineering. This... ...and ensuring compliance with regulatory standards. Continuous improvement... ..., Six Sigma, and 5S, will be championed to reduce costs and improve...QualityRegulatory
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