Senior Quality Operations Leader - Medical Device NPI & CAPA
Mass Digital Health
Philips is seeking a Senior Quality Operations Manager-Advanced Imaging in Bedford, MA to lead quality operations for medical devices. The role drives CAPA/NC/QN processes, process validation, and risk management while coordinating across R&D, manufacturing, and regulatory affairs to uphold regulatory standards and excellent product quality. You will manage a quality team, oversee audits, and support PFMEA assessments, change/risk management, and NPI/product transfers, ensuring robust quality #J-18808-Ljbffr Mass Digital Health
$134k - $213k
Senior Quality Operations Manager-Advanced Imaging Job Description The Senior Quality... ...efficiency, managing CAPA/Nonconformance processes and... ...New Product Introduction (NPI) or product transfers into... ...FDA regulated (ISO 13485) medical device quality operations/manufacturing...QualitySeniorMedical deviceFull timeWork at officeLocal areaImmediate startWork visaRelocation package3 days per week- Stevenson Search Partners is seeking a Senior Supplier Quality Engineer - Plastics for a medical device client in the United States. You will own supplier quality deliverables... ..., lead plastics supplier evaluation, and drive CAPA and continuous improvement across a global network...QualitySeniorMedical device
$134k - $213k
Senior Quality Manager-Advanced Imaging The Senior Quality Manager-Advanced... ...QMSR, ISO 13485, European Medical Device Regulation (MDR), and other... ...-functionally with R&D, Operations, Regulatory Affairs, and other... ...investigations, root cause analyses, CAPA activities, nonconformance...QualitySeniorMedical deviceFull timeWork at office3 days per week- ...International is recruiting for a Post Market Surveillance Quality Engineer for a leading medical device innovator in Massachusetts. The role monitors device... .../FDA requirements, and statistical methods to drive CAPA and continuous improvement, collaborating with...QualityMedical device
- BioTalent in Massachusetts is seeking a Senior Regulatory Affairs Specialist to lead and execute regulatory strategies for complex Class III medical devices, collaborating with Clinical, Quality, R&D and Manufacturing teams in a fast-paced, growth-oriented environment....QualitySeniorMedical device
- ...Massachusetts is seeking a skilled Software Engineer focused on Medical Device Software Development. You will design, build, and maintain... ...Python, and C++/C#. You will drive automation, contribute to quality assurance, and collaborate to deliver innovative solutions in...QualitySeniorMedical device
- ...cross-functional teams, including software engineers, quality assurance, and technical leaders, to understand their needs and deliver tailored... ...OR PhD with 0 years relevant experience Knowledge of Medical device software development, IEC- 62304 and FDA guidance in...QualitySeniorMedical device
- Bristol Myers Squibb in Devens, MA is seeking a Sr Manager QA Technical Operations to lead a team overseeing quality control projects, tech transfer, validation, and manufacturing support. The role requires directing change controls, site engineering maintenance programs...QualitySenior
- Philips in Bedford, MA is seeking a Senior Quality Manager-Advanced Imaging to lead the QMS and design assurance across the product lifecycle... ...audits, and drive continuous improvement in a regulated medical device environment. The role requires 8+ years in FDA-regulated...QualitySeniorMedical deviceWork at office
- Our client, an innovative medical device company, is seeking a Senior Regulatory Affairs Specialist to support regulatory strategy and submissions for complex... ...activities while working closely with Clinical, Quality, R&D, and Manufacturing teams in a fast-paced, growth-...QualitySeniorMedical deviceShift work
- ...Partnering cross-functionally with R&D, Quality, Manufacturing, and Clinical... ...of Regulatory Affairs experience in medical devices Direct hands-on experience authoring... ...interviews with the team. If you’re currently operating at a Senior level and ready for greater ownership...QualitySeniorMedical deviceRemote work
- ...Oklahoma City is seeking a Reconditioning Operations Leader to oversee multiple reconditioning... ...shifts and ensuring targets are met for quality, cost, and throughput. You will lead a... ...conduct weekly performance reviews with senior leadership, and coach site managers on...QualitySeniorShift work
- ...Site Manager based in Oklahoma City. The role involves leading operations at a rapidly growing workforce accommodations facility,... ...responsible for up to 4,000 rooms. The Site Manager will ensure high-quality hospitality services, manage staffing and financial oversight,...QualitySenior
- ...regulatory agencies for new and existing devices. Lead and influence the preparation of documentation... ...to support innovative and high-quality regulatory submissions from early phase... ...Regulatory Affairs experience within the medical device industry Or advanced degree with a...QualitySeniorMedical deviceWork at office
- ...manufacturing partners supporting device supply Ensure reliable supply, technical and operational issue resolution, project... ...across Amgen, supplier sites, quality, supply chain, engineering, procurement... ...pharmaceutical, biotechnology, medical device, combination product,...QualitySeniorMedical device
- ...Senior Vice President, AI Transformation... ...Specialties medical communications... ...advertising medical device marketing payer... ...into the firm's core operations. The successful candidate... ...with the required quality, and are... ...The role demands a leader who is comfortable...QualitySeniorMedical device
- Responsibilities Partner with the Device Regulatory Lead on assigned... ...innovative and sustainable medical device regulatory strategies... ...product changes Support operational and compliance activities for... ..., Device, Manufacturing, and Quality teams Strong written and verbal...QualitySeniorMedical device
$151k - $215k
...we do. As part of our Medical Affairs team, you'll foster... ...lives and advance the quality of care. Your... ...inspiring journey. The Senior Principal Biostatistician... ...Biostatistics Standard Operating Procedures (SOPs) and Work... ...Preferred): Medical device industry experience strongly...QualitySeniorMedical deviceFull timeRemote work- ...Minneapolis (Minnesota). The Senior Desktop UI Software Engineer... ...of our advanced medical devices. The ideal candidate should... ...Develop and maintain high‑quality, scalable, and maintainable... ...Python, and QML on a Linux operating system. Collaborate with cross...QualitySeniorMedical device
- • Partner with the Device Regulatory Lead on assigned projects •... ...execute innovative and sustainable medical device regulatory strategies... ...product changes • Supports operational and compliance activities for... ..., Device, Manufacturing, and Quality teams Strong written and...QualitySeniorMedical device
- ...communications Partner with Marketing, Medical Affairs, Legal, and Regulatory stakeholders... ...members to build capabilities in content quality, compliance, and review standards... ...Strong understanding of healthcare, medical device, or life sciences industry standards Demonstrated...QualitySeniorMedical device
- Warehouse Specialist / Senior Specialist Location: Oklahoma City... ...day-to-day cGMP warehouse operations, including material receipt,... ...partnership with Leadership and Quality Assurance. Maintain clean,... ...environment (cGMP, Pharma, Medical Device, or Dietary Supplements) is...QualitySeniorMedical deviceFull timeContract work
$94k - $150k
Senior Regulatory Affairs Specialist Job Description Senior Regulatory Affairs Specialist... ...Files, Declarations of Conformity, and Medical Device Licenses—for various global markets.... ...everybody everywhere has access to the quality healthcare that we all deserve. Do the work...QualitySeniorMedical deviceFull timeWork at officeWork visaRelocation package3 days per week- ...their own as digital leaders. Ready to find genius... ...Fusion Manufacturing Senior Manager to lead large-... ...modernize manufacturing operations through Oracle Fusion... ...GMP, GxP, and global quality standards.The successful... ...pharmaceutical, biotechnology, medical device, and life sciences...QualitySeniorMedical deviceFull timeWork experience placementLive inWork at officeLocal area
- ...processes within established medical product design controls. Design... ...functions, and performance. Work with senior leadership to improve software... ..., specifications and meet quality standards. Assist with project... .... Experience of medical device development processes and FDA...QualitySeniorMedical device
- ...Schedule: Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is... ...Responsible for the following quality management sub-systems: Post Market... ...-systems to assure effective operational execution of assigned...QualitySeniorMedical deviceLocal areaShift workNight shift
- ...and regulatory requirements. This role supports complaint handling, investigation, CAPA management, and quality system improvements across small molecule, biologic, and medical device products. Key Responsibilities: Manage product complaint intake, triage, investigation...QualityMedical device
- ...seeking an experienced QC Analyst III to join our GMP-regulated Quality Control team. The role leads analytical testing across early development... ...gel electrophoresis and microscopy, supporting investigations, CAPAs, and regulatory inspections while collaborating with QA,...QualitySenior
$120k - $140k
Freudenberg Group is seeking a Program Manager for their Beverly, MA location in the medical device sector. The Program Manager will oversee product development cycles, manage budgets, and mentor teams while ensuring compliance with regulatory standards. This role requires...SeniorMedical device- ...role drives growth through strategic planning, leadership, and business development, requiring extensive sales experience in the medical device industry. Your responsibilities include developing business plans and overseeing a sales team while fostering key client...SeniorMedical device
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