Senior Quality Operations Leader: CAPA, PFMEA & NPI
Philips
Philips in Bedford, MA, seeks a Senior Quality Operations Manager to oversee strategic process validation initiatives, drive improvements in product quality and manufacturing efficiency, and manage CAPA/Nonconformance processes. You will lead a quality team and ensure regulatory standards and QMS compliance across NPI and product transfers. The role requires 10+ years in FDA-regulated medical device quality operations, with at least 3+ years leading teams. #J-18808-Ljbffr Philips
$134k - $213k
Senior Quality Operations Manager-Advanced Imaging### Job DescriptionThe Senior Quality... ...efficiency, managing CAPA/Nonconformance processes and... ...Mode and Effects Analysis (PFMEA) and associated controls in... ...of New Product Introduction (NPI) or product transfers into factory...QualitySeniorFull timeWork at officeLocal areaWork visaRelocation package3 days per week- Philips is seeking an on-site Logistics and Warehouse Operations Manager in Bedford, MA to lead end-to-end warehouse and transportation activities, focusing on quality, patient safety, and regulatory compliance. The role requires managing 3PL partners, optimizing inventory...QualitySenior
- Curtiss-Wright Defense Solutions in Massachusetts seeks a Senior Manager, Operations to lead production, quality, and supply chain for TCG products. You will direct production lines, oversee inventory controls, and ensure on-time delivery while aligning with leadership...QualitySenior
- Curtiss-Wright Defense Solutions in Massachusetts seeks a Senior Manager, Operations to lead all production, quality, and supply chain functions across the site in Tewksbury. You will partner with the GM, Director, and Engineering to develop and execute the production...QualitySenior
- ...Pharmacy Services, Inc. is seeking a Program Operations Manager to lead the Massachusetts State... ...for Pharmacy Services (SOPS) contract. This senior role ensures operational excellence, regulatory compliance, and continuous quality improvement across a high-volume...QualitySeniorContract workWork at office
- Teleflex is seeking a Sr. Quality Engineer (CAPA and PMO) to lead investigations of complex quality issues within CAPA, partnering with Quality, Manufacturing, Engineering, Operations, and Supply Chain. The role requires strong analytical thinking, investigational rigor...QualitySenior
- Analog Devices, Inc. seeks an experienced Senior Medical Quality Engineer to ensure quality, safety,... ...with engineering, regulatory, and operations to drive quality across the product lifecycle... ...‑solving, and leadership in audits, CAPA, and process improvements in a global...QualitySenior
$110k - $120k
...precision, reliability, and quality matter every time. Because engineering... .... About the Role As a Senior Quality Systems Specialist at... ...day while partnering with Operations, Engineering, Regulatory, and... ...like document control, CAPA, nonconformance, and supplier...QualitySenior$100k
...Senior Quality Engineer Location: Devens, MA Job Type: Direct Hire / Full-Time Salary... ..., ISO standards, process validation, CAPA, and risk management , this could be an... ...teams during New Product Introduction (NPI), product development, and product changes...QualitySeniorFull timeTemporary workLocal area- What You’ll DoThe Senior Manager, Quality Control leads daily operations of the Quality Control testing laboratory, ensuring... ...serve as a hands-on technical leader with deep technical expertise in... ...protocols.• Manage lab deviations, CAPAs (Corrective and Preventive...QualitySeniorFull timeImmediate start
$111.97k - $141.83k
...ManufacturingVeeco is the world leader in Ion Beam... ....As a Senior Manufacturing... ...with hardware, Quality, Reliability,... ...initiatives, support PFMEA-based risk... ..., and operational efficiency.Identify... ...Why, Fishbone, CAPA, and other structured... ...engineering, NPI, or production...QualitySenior$250k - $273k
...accomplished life sciences leaders. At Kiniksa, talented individuals... ...it most.We're seeking a Senior Director, Quality Compliance reporting to the... ...consistent compliance, operational effectiveness, and continuous... ...root cause analysis and CAPA effectiveness.Partner with...QualitySeniorWork at office- ...seeking an experienced and driven Senior Mechanical Engineer to join... ..., Program Management, and Operations to drive products from concept... ...Support New Product Introduction (NPI) activities, including early... ...engineering, incorporating production, quality, and field feedback into...QualitySeniorFull timeLocal areaRelocation package
$130k - $140k
...communities. An industry leader in X-ray inspection... ...The Supplier Quality Engineer (SQE) serves... ...preventive action (CAPA) activities.... ...Product Introduction (NPI) activities to ensure... ...improvement initiatives to senior leadership.... ...Systems, Inc. has three operating divisions: (a)...QualitySeniorFull timeWork at officeFlexible hours- ...Operations Leader The Operations Leader's main role is to create a collaborative and positive work environment for all our members. The... ...Team meets our partner's expectations and achieves our high-quality standards. It's the Operations Leader's duty to lead, guide,...Quality
- ...-01305Job Summary: The Senior Manufacturing Engineer... ...to improve efficiency, quality, and cost-effectiveness... ...and preventive actions (CAPA). Ensure compliance with... ...degree in Management, Operations, Engineering, or a closely... ...including PFMEA, IQ, TMV, OQ/PQ, and statistical...QualitySenior
$195.5k - $293.3k
...Your Role: The Compound Operational Lead (COL) is a global... ...budget, timelines and quality standards agreed upon... ...delivery of program CAPAs to meet corporate compliance... .../managers/team leaders) and is accountable for... ...5 or more years in a senior leadership position directing...QualityFlexible hours$85.4k - $158.6k
...Reporting: Associate Director, Quality Assurance Description :... ...are seeking an experienced Senior Quality Assurance Specialist,... ...QA oversight to daily operations, supports batch review and release... ...release, manages deviations and CAPAs, and partners closely with...QualitySenior- ...Farms Marketplace in Cambridge, MA is seeking an experienced Deli Operations Manager to lead the Deli and Prepared Foods Department,... ...leadership, the ability to train and develop a team, and a focus on food safety, hospitality, and quality. #J-18808-Ljbffr Pemberton FarmsQualitySenior
$95k - $130k
...NPI Operations Program Manager At Formlabs, we're building the tools that make it possible... ...innovation at more than 50,000 industry leaders worldwide, including Apple, Google,... ...possible on time, budget, and with the right quality product meeting technical requirements....QualityFull timeWork at officeWorldwideFlexible hours$200k - $260k
...Company on LinkedIn and X. We are seeking a Director/Senior Director, GMP Quality Assurance Operations. You will be responsible for providing strategic and... ...systems, including deviations, investigations, CAPAs, change control, batch review, CPV, OOS/OOT/OOE management...QualitySeniorContract workTemporary workFlexible hours- ...SCOPE: The Sr. Manager CAPA is responsible for... ...Systems (GMS) and associated operational and business systems.... ...all regulatory and quality requirements while meeting... ...collaboratively with leaders employees and all... ...Ability to influence senior stakeholders and drive...QualitySeniorFull timeWork experience placementLocal area
- ...processes for design and manufacturing product transfer.Ensure product quality is achieved at the receiving manufacturing site level during... ...defined quality planning, including site registration, defined pfmea at receiving sites, training requirements established,...QualitySeniorFull timeImmediate start
$160k - $170k
...accomplished life sciences leaders. At Kiniksa, talented... ...Supply Chain, the Senior Manager, Clinical Supply... ...Management will provide operational leadership and cross-functional... ...Clinical Operations, Quality, Regulatory, CMC/... ...readiness and deviation/CAPA investigations as applicableExtensive...QualitySeniorContract workWork at officeFlexible hours- Intepros is seeking a Sr. Supplier Quality Engineer to lead supplier quality activities, qualification... .... The role partners with engineering and operations to ensure GMP and regulatory compliance... ...manage supplier audits, ASL processes, CAPA/NCMR, and change requests, mentor teams,...QualitySenior
- ...our pigs. POSITION SUMMARY The Senior Quality Systems Specialist will be supporting... ...initiate, support and manage deviations and CAPAs ensuring timely closure across all... ...Bachelor’s degree in a scientific or operational discipline relevant to the life sciences...QualitySenior
- What You’ll DoThe Senior Quality Engineer is responsible for supporting the effective establishment and maintenance of the Anika Quality System... ...investigations for manufacturing issues, complaints, and CAPAs with full cross-functional engagements.Review and approve CAPAs...QualitySeniorFull timeWork at officeImmediate start
$148k - $180k
...our Waltham, MA or Newark, CA office.Position Summary: The Senior Quality Operations Manager provides day-to-day Quality oversight of CMOs, suppliers... ...external deviations, investigations, change controls, CAPAs, and effectiveness checksProvide Quality oversight of technology...QualitySeniorFull timeContract workWork at officeFlexible hours2 days per week3 days per week- ...Job Description Job Description Senior Director, Quality Control At Vericel Corporation, we... ...role leads Quality Control laboratory operations and testing oversight, including product... ...and processes. The role develops leaders and technical staff, ensures inspection...QualitySeniorContract workWork at officeMonday to Friday
- ...seeks an experienced Imaging Services Director to plan, organize and direct imaging staff across diagnostic imaging, ensuring high-quality results and patient care. The role manages budgets, collaborates with leadership, and ensures compliance with applicable regulations...Quality
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