Quality Systems Leader, Medical Devices & Compliance
Gentuity
Gentuity in Sudbury, MA is seeking an experienced QMS leader to ensure compliance with FDA, ISO, and global requirements. You will own document control, CAPA, supplier qualification, and major quality initiatives. The role requires extensive experience in medical devices, strong audit capabilities, and a proven track record in training and leading teams. You will drive metrics, support management reviews, and coordinate cross‑functional improvement projects. #J-18808-Ljbffr Gentuity
- Description Manage QMS compliance with the appropriate internal and... ...requirements). Manage Document Control system, including the Change Order... .... Own the development of Quality Metrics, and coordinate... ...7 years of experience in a Medical Device environment, 3-5 years...QualityMedical device
$128.75k - $163.08k
...Information Technology, Legal, and Compliance. This team ensures the... ...retinal diseases.The IT System and Validation Analyst is responsible... ...Operations, Facilities, Quality Control, Quality Assurance,... ..., biotechnology, medical device, or similar).EyePoint is committed...QualityMedical device- ...V&V, and traceability from design input to output. This hands-on leader will set system integration strategies, develop plans and validation docs, and work with Mechanical, Electrical, Software, Quality, Regulatory, and PM teams while mentoring a five-member team. Travel...QualityMedical device
$110k - $160k
A leading diagnostics company in Massachusetts seeks a Senior Manager, Quality Systems to oversee global process design and compliance. The role involves developing global policies aligned with regulatory standards and driving process maturity. Candidates should have over...Quality$131.7k
...and commercial impact. This leader will manage a blended team... ...alignment with Boston Scientific quality, compliance, privacy, procurement, and... ...and commercial priorities. Medical device, field sales, sales... ...Mindtickle, SharePoint, or similar systems. Demonstrated success using...QualityMedical deviceHourly payWork at officeLocal areaRelocationRelocation packageShift work3 days per week- Replimune seeks a Quality Systems specialist to administer and optimize eQMS platforms, ensuring regulatory compliance and inspection readiness. The role supports governance, workflows, and cross-functional collaboration across sites. The ideal candidate has deep GxP experience...Quality
- ...programs under cGMP conditions, ensuring product quality, regulatory compliance, and timely release of materials. In this... ...laboratory instrumentation, and quality control systems within regulated pharmaceutical and medical device environments. • Perform analytical testing...QualityMedical deviceFull timeImmediate start
- ..., product reliability, and a five-person systems engineering team, while guiding requirements... ...output. The role requires FDA-regulated device experience, a strong leadership presence,... ...across mechanical, electrical, software, quality, regulatory, and project management teams...QualityMedical device
- ...Reviews manufacturing documentation for compliance.Coordinates sample preparation and... ...management.Assists Lead Technician in quality system generation, reviewing log books and non... ...to HaveManufacturing experience in the medical device industry.Experience working in a clean...QualityMedical deviceFull timeWork at officeImmediate startFlexible hoursAfternoon shift
- ...ERP transactions, and maintain compliance with 21 CFR and ISO 13485 standards in a medical device manufacturing environment. Responsibilities... ...Operate computers, SAP/ERP systems, printers, pallet jacks, and... ...with a strong focus on quality and safety. Positive team player...QualityMedical deviceShift work
- ...to pharmaceutical companies, medical device companies, biotech... ...pharmacovigilance, regulatory affairs, quality assurance, quality control,... ...while ensuring quality, compliance, and client satisfaction.Job... ...ensure data integrity across systems (e.g., new hires, terminations...QualityMedical deviceContract workLocal area
- What You’ll DoThe Senior Quality Assurance Specialist provides quality... ...chain activities, ensuring compliance with global regulatory... ...matter expert in GMP quality systems, CMC quality oversight, and... ...understanding of pharmaceutical and medical device Quality Management Systems.•...QualityMedical deviceFull timeContract workImmediate start
- ...Intuvie is seeking a Director of System Engineering in Natick, MA to lead the system-level... ...role requires a strong background in medical device development, regulatory submissions, and... ...and Waterfall processes to deliver high-quality system-level deliverables. #J-18808-Ljbffr...QualityMedical deviceFor contractors
$25 per hour
...Quality Inspector Location: Marlborough, MA Onsite Flexibility: Onsite... ...process quality oversight, and regulatory compliance within a medical device manufacturing environment. The... ...Product Lifecycle Management (PLM) system, including identification, quarantine...QualityMedical deviceContract workWork visa- Responsible for maintaining quality standards for Ocular’s pharmaceutical and medical device products by managing activities associated with Supplier Quality... ...is reporting to the Sr. Director of Quality Systems and Compliance. Principal Duties and Responsibilities...QualityMedical deviceFull time
$32.21 - $41.76 per hour
...a strong focus onregulatory compliance, patient safety, and product... ...goal of delivering safe, high-quality therapies to patients. The... ...Practices (GDP), and quality system requirements. Proficiency in... ...environment. Experience in medical device, pharmaceutical, biotechnology...QualityMedical device- IPG Medical CorporationIPG Medical Corporation is focused on developing... ...develop innovative medical device laser solutions that make... ...advertising materials for compliance with global regulations;... ...databases as needed.Support quality system audits by notified bodies, government...QualityMedical device
- ...Job Description Industry: Medical Devices / Healthcare Technology... ...Job Function: Engineering / Quality Management Education Level... ...activities, ensuring product compliance and high operational standards... ...KPIs, risk trends, and systemic improvements. Must-Have Qualifications...QualityMedical deviceRelocation packageFlexible hours
$80k
...organ transportation devices that safeguard organs... ...clinically proven and medically trusted hypothermic preservation... ...in a novel suspension system to provide... ...to improve donor organ quality and extend donor organ... ...instability, and regulatory compliance issues. Education...QualityMedical deviceContract work- ...Role Join a growing medical device manufacturer in Littleton... ...our next Operations Quality Manager — a role... ...for a hands-on quality leader who wants real ownership... ...just enforce a quality system; you'll shape it. You'... ...of launch. Ensure compliance with FDA QMSR, ISO 134...QualityMedical deviceRelocation packageFlexible hours
$180k - $200k
...event reporting, recalls, and compliance with international market... ...processes in a high-volume IVD or medical device environment . You will lead... ...post-market surveillance systems in accordance with EU IVDR... ...activities , working closely with Quality and Compliance teams Serve...QualityMedical deviceFull timeContract workRemote work$200k - $220k
...0.00/yr - $220,000.00/yr Our medical device client is hiring a Sr. Director, Design and Supplier Quality Assurance to join their team!... ...Method Validation (TMV), Computer System/Software (non-product)... ..., labeling and sterilization compliance, and periodic/ad-hoc risk reviews...QualityMedical deviceFull time- ...Quality Control Inspector Perform inspection of incoming materials, components, and... ...testing techniques. Electronic Quality System experience. Proficient with Microsoft... ...Excel, and other electronic systems. Medical device experience is a plus. Experience working...QualityMedical deviceFor contractorsWork at office
- ...Takeda is seeking a Lead Engineer to oversee operations for medical devices, focusing on design, testing, and ensuring compliance with quality, safety, and performance standards. You will develop protocols, maintain GxP compliance, and lead activities like test method...QualityMedical device
- ...day remote)Industry: Medical DeviceEmployment Type:... ...innovation-driven medical device company focused on... ...building a culture of quality, execution, and smart... ...team; ensure continued compliance with FDA, ISO 13485, MDSAP... ...development, quality systems, and future growth...QualityMedical deviceFull timeRemote work
- ...new product development, coordinating with R&D, Regulatory, Quality, Operations, and Marketing to ensure successful launches and... ...requires senior-level product management experience in IVD or medical devices, a track record of revenue growth, and #J-18808-Ljbffr WerfenQualityMedical device
$75.41k - $103.69k
Job Purpose As a Quality Systems Engineer, you will be responsible for helping to ensure the... ...processes are executed compliantly. QMS compliance will be met by ensuring that... ...Qualifications 3+ years’ experience working in the medical device or aerospace fields with experience in...QualityMedical device- ...implementation of labeling for Medical Device UDI project? Do you want to... ..., UDI and EUDAMED in compliance with the internal and key external... ....Develops and maintain a quality plan to define all key milestones... ...to develop the procedures, system changes, validation etc. to...QualityMedical device
- Sanofi in Framingham, MA is seeking a Head of Quality Compliance to oversee GMP activities and compliance programs across site operations including... ...improvement while maintaining a robust quality management system. The candidate will oversee relationships with regulators and...Quality
$110k - $160k
Senior Manager, Quality Systems (Global Process Owner) Reporting... ..., and developmental. Medical/Prescription Drugs... ...performance and compliance through dashboards, audits... ...with Site Quality leaders, Operations, R&D, IT,... ...diagnostics, medical devices, or laboratory services...QualityMedical deviceTemporary workWork experience placementWork at officeLocal areaWork from homeFlexible hours
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