ISO 13485 CAPA Quality Systems Specialist
Merrimack Manufacturing
Merrimack Manufacturing is seeking a Quality System Specialist - CAPA to support and maintain the QMS in line with ISO 13485 and FDA QSR requirements. This role focuses on coordinating, tracking, and verifying CAPA and NC processes while collaborating across functions to ensure timely investigations, resolutions, and closures. The position also supports internal audits, change control, management review preparation, and continuous improvement initiatives, providing essential documentation and #J-18808-Ljbffr Merrimack Manufacturing
- Position Summary The Quality System Specialist - CAPA is responsible for supporting and maintaining the Quality Management System (QMS) in compliance with ISO 13485 and applicable regulatory requirements for medical device operations. This role is primarily focused on...SuggestedWork at office
- ...behalf of Millyard Advanced Medical Products, is looking for a Quality Systems Specialis t to work in a dynamic Medical Device Research and... ...without degree ~ Understanding and working knowledge of ISO 13485 and Quality System regulation is required ~ Proficient in...SuggestedFull timeContract workWork at office
- DEKA Research & Development in Manchester, NH, seeks a Quality Systems Specialist to maintain and improve the quality management system in a dynamic medical device R&D setting. This high visibility role reports to the Director of Quality and directly impacts quality records...Suggested
$95k - $124k
Department: 107100 Quality Location: San Diego, USA- Remote Be a... ...Position Summary The Senior Specialist, Quality Assurance Technical,... ...utilizing the Quality Management System (Veeva): Protocols and... ...Laboratory Investigations Associated CAPA and Effectiveness Checks...SuggestedContract workTemporary workInterim roleRemote work$95k - $124k
Department: 107100 Quality Location: San Diego, USA- Remote Be a part... ...with applicable FDA, EU, ICH, ISO, and other regulatory... ...corrective and preventive action (CAPA) plans. Track audit findings... ...risks as appropriate. Quality Systems & Compliance Support GxP inspection...SuggestedContract workTemporary workRemote work- ...DESCRIPTION:Position Title: QA Specialist ILocation: Bedford, New HampshireDepartment: Quality AssuranceReporting To: QA Supervisor... ..., Lot Disposition, and Quality System review. This position will also... ...and monitoring the associated CAPAs. In this role, the opportunity exists...Full time
- ...future of PCI.Position Title: QA Specialist II - Document ControlLocation... ..., New HampshireDepartment: Quality Assurance, Document... ...databases and Quality Management System tools and supports personnel... ...Quality System Investigation and CAPA action itemsTrain others in doc...Full time
- ...QA Specialist I will oversee batch record reviews, lot disposition, and quality system administration for clinical and commercial pharmaceutical products. The role involves... ...deviation management, investigation oversight, CAPA coordination, and cross-functional collaboration...
- ...PCI Pharma Services seeks a QA Specialist II for Document Control in Bedford, New Hampshire... ...document workflows, maintaining quality management systems, and leading continuous improvement... ...Lead quality system investigations, CAPA action items, and audit preparation activities...
- ...Quality Assurance Specialist supporting clinical and commercial pharmaceutical manufacturing at a contract... ...management, investigations, and CAPAs to ensure GMP compliance and product quality... ...Review, develop, and approve quality system procedures, specifications, test methods...Contract work
- ...(DME) company that provides the highest quality level of service for patients in need of... ...receiving the best care possible. The Quality Specialist reviews patient charts and sales orders... ...in E-Verify. E-Verify is a web-based system that allows an employer to determine an...Work at office
- ...DESCRIPTION:Position Title: QA Specialist II - Ops/Floor... ...Bedford, New HampshireDepartment: Quality Assurance OperationsReporting... ...monitoring of manufacturing related systems and processes to ensure compliance... ...Quality Systems (deviations, CAPA, Nonconformances).Perform...Full timeImmediate startShift work
$65k - $70k
...Position Summary: The Quality Control Field Specialist is responsible for overseeing and continuously improving quality standards across warehouse... ...and company policies; identify risks and escalate systemic issues proactively. 5% Required Education Associate...Full timeH1bWork at officeLocal area- ...pioneer and shape the future of PCI.JOB DESCRIPTION:Position Title: Sr. QA Specialist - Supplier QualityLocation: Bedford, New HampshireDepartment: Quality AssuranceReporting To: QA Dir, Quality Systems & ComplianceResponsible For (Staff): NoThis position is part of PCI’s...Full timeContract work
- ...pioneer and shape the future of PCI.This position is part of PCI’s Quality Compliance team responsible for the quality aspects of supplier... ....Support Annual Product Quality Review’s.Support Quality System events impacting the Supplier Quality program.Request, reconcile...Full timeContract work
- ...future of PCI.Summary of Objective:This position is part of PCI’s Quality Compliance team responsible for the quality aspects of supplier... ....Support Annual Product Quality Review’s.Support Quality System Events impacting the Supplier Quality program.Request, reconcile...Full timeContract work
$159.43k
...make a difference and change the world. Job Description Job Duties: • Develop, implement, and maintain the project-specific Quality Assurance Surveillance Plan (QASP) in compliance with Federal Acquisition Regulations (FAR), Construction Quality Management (CQM)...Contract workFor contractorsWork experience placementFor subcontractorH1bImmediate startFlexible hours- ...Chief Quality Officer (CQO) About the Company Highly technically advanced hospital network in New England Industry Hospital... ...the quality infrastructure with the clinical services operating system and identifying opportunities to expand and optimize its impact...
- ...PCI Pharma Services seeks a QA Specialist II to oversee supplier qualification and compliance... ...to evaluate compliance with SOPs, quality and regulatory standards Track supplier... ...biotech, or medical device GMP quality systems Exceptional organizational and interpersonal...
- ...detail keeps our products compliant and customers confident. As a Quality Visual Inspector, you’ll move between drawings, parts, and data... ...and complete FAIs with accuracy and clarity. Strengthen the system: Support and maintain our AS9100 Quality Management System and...
- ...QA Specialist Compliance Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.... ...and shape the future of PCI. Reporting to the Director of Quality Systems & Compliance, the QA Specialist Compliance is responsible for...Weekend work
- ...excellent opportunity for a Program Consultant focused on Health Care Quality Improvement. This remote role serves ME, NH, VT, and NY, with... ...commitments. You will collaborate with hospitals and health systems to implement Get With The Guidelines and drive program...Remote jobLocal areaNight shift
- ...NH is hiring a Raw Processor to receive, test, and separate raw milk; input results into SAP; perform raw CIP and cleaning; support quality standards. You will operate a milk separator, manage load outs and bagging, program HMI, assist pasteurized processing, and follow...Shift workWeekend work
- Travere Therapeutics is seeking a Senior Specialist in Quality Assurance Technical to support qualification/validation activities for solid oral dose and biologic programs. The role ensures quality and compliance with regulatory requirements across clinical and ongoing...Remote job
- Lactalis USA in Londonderry, NH is seeking an FSQ Customer Support Analyst to ensure product quality and food safety compliance, manage documentation, and support export/import needs. You will work with plant quality, corporate quality, R&D, sales, and external partners...
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