Clinical QA Investigator - Medical Devices
Hologic, Inc.
Hologic, Inc. in Marlborough, MA is seeking a Clinical QA Specialist to investigate and report adverse events and support regulatory reporting activities across FDA/ISO frameworks. You will collaborate with Technical Service, Marketing, Sales, and Regulatory to ensure timely, thorough documentation, analysis, and CAPA-driven improvements in post-market surveillance. Ideal candidates have 5+ years in medical device QA/regulatory roles and a strong foundation in risk management. #J-18808-Ljbffr Hologic, Inc.
- Are you passionate about ensuring compliance and patient safety in the medical device industry? At Hologic, we are seeking a Clinical QA Specialist to play a critical role in the investigation and reporting of potential and actual adverse events, as well as other regulatory...Medical device
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$34 - $51.25 per hour
...Clinical Research Coordinator The Clinical Research Coordinator is responsible for supporting the management and execution of clinical... ...: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with...Medical deviceFull timeWork at officeRemote workFlexible hours- Senior Design Quality Assurance Engineer - Medical Device #7016 (Project Management) About ECI ECIs mission is to be the global leader... ...as design changes, supplier auditing, and customer complaint investigations Identify, prioritize, communicate, and resolve quality...Medical deviceVisa sponsorshipWork visaFlexible hours
$200k - $220k
...A leading medical device firm in Hudson, MA is seeking a Sr. Director, Design and Supplier Quality Assurance. This role involves global leadership for NPI design controls and ensuring compliance with quality standards. Candidates must possess a Bachelor's degree in engineering...Medical device- ...alignment with regulatory and corporate standards.KnowledgeIn-depth understanding of quality management systems, especially in the medical device or related industryStrong knowledge of applicable regulations and standards, particularly ISO13485 and 21CFR Part 820...Medical deviceWork at office
$200k - $220k
...learn more. Base pay range $200,000.00/yr - $220,000.00/yr Our medical device client is hiring a Sr. Director, Design and Supplier Quality... ..., MA $70,000.00-$80,000.00 2 weeks ago Executive Director, Clinical Quality Assurance Bedford, MA $259,000.00-$276,000.00 3 days...Medical deviceFull time- ...passionate about ensuring the safety and reliability of life-saving medical devices? At Hologic, we are seeking a Quality Assurance Engineer -... ...and creating training materials.Ability to conduct complex investigations and provide clarity into root cause findings.Proficiency in...Medical device
- ..., and commercialization of innovative medical devices from concept through launch and sustaining... ...teams, translating customer, clinical, and business needs into robust, manufacturable... ....Experience with root cause investigation, design for reliability, supplier development...Medical device
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- Currently supporting a growing, founder-led Medical Device company seeking a Director Quality Assurance! The business operates across multiple... ...preferred Experience managing cross-functional teams within QA/QC and design quality environments Strong leadership capability...Medical deviceContract work
- ...functional groups including research and development, marketing, clinical, medical safety, design quality, regulatory affairs, process... ...development team.Preferred QualificationsExperience in the medical device industry PMP certification Requisition ID: 536470 As a leader...Medical deviceRemote workWorldwide
$35 - $40 per hour
...drugs. They are looking for a skilled QA Inspector II to join their growing team... ...materials to management and support root cause investigations. Assist with corrective actions,... ...Quality Management System. Experience with medical devices, bioprocessing equipment, military, or...Medical deviceContract workWork at office$140k - $160k
...communication across US Sales Channels.Required Qualifications:Bachelor’s DegreeMinimum of 8 years of experience within healthcare/medical device industry in a commercial role (i.e downstream marketing or sales)Understanding of: Healthcare contracting structures (tiers,...Medical deviceFull timeContract workRelocation package- ...or Master's level programAt least 8 years relevant industry experience (e.g. GMP medical device, pharmaceutical) requiredAt least 5 years relevant QMS experience dealing with investigations, CAPA, change control, risk management.) required; 6-8 years preferredExtensive...Medical device3 days per week
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- ...solutions to pharmaceutical companies, medical device companies, biotech organizations, CROs... ...and consulting staffing needs across clinical research, pharmacovigilance, regulatory... ...Relations Specialist also conducts investigations, develops performance improvement plans...Medical deviceContract work2 days per week1 day per week
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