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Job alert Jobs 11 - 20 of 879

Post Market Surveillance Analyst/Complaint Investigation Specialist

Select Source International  –  Burlington, MA
... Complete FDA MDR and other outside competent authority regulatory reports.Company Description Select Source International (SSI) is an IT, Health Care, and Engineering Services consulting firm that has been in business since 1998. SSI consultants ... - Jun 09

Clinical Operations Manager

Access Vascular  –  Billerica, MA
... Regulatory Compliance: Maintain strict adherence to relevant regulations (e.g., FDA, ISO) throughout the trial lifecycle. Accurately document all compliance-related activities. Study Oversight: Monitor study progress, patient recruitment, data ... - Jun 02

Project Manager- must have med device & quality engineer experience

Diverse Lynx  –  Danvers, MA, 01923
... • Knowledge on Quality Management and its tools & techniques • Knowledge about FDA, ISO 13485 and compliance regulations • Knowledge on Medical Device Regulatory Standards, MDD and MDR • Knowledge on NC, CAPA, Audit processes • Knowledge in ... - May 29

Quality Engineer

G & F Precision Molding Inc  –  Danvers, MA, 01923
... Having FDA Regulatory experience is a plus. Occasional travel to our Danvers, MA location is required. Job Type: Full-time Salary: $80,000 - $90,000 per year Benefits: 401(k) 401(k) matching Dental insurance Dependent care account Employee ... - Jun 05

Principal Supplier Quality Engineer

InfraredX, Inc.  –  Bedford, MA, 01730
... Maintain supplier quality records in accordance with FDA/GMP and EU MDR requirements. Lead the review of supplier change requests with cross-functional team, including evaluation of change, implementation planning, and approval. Generate KPI’s and ... - May 16

Sr. Manager, Quality Assurance

EPM Scientific  –  Billerica, MA, 01821
... 8-10 years of Quality experience in medical device, combination product experience preferred Direct experience with medical device complaints investigations and inspection readiness Experience working directly with FDA/notified bodies Must be ... - May 26

Software Engineer

Engtal  –  Andover, MA
... Formulate and uphold software development protocols in compliance with regulatory standards, including FDA guidance and IEC 62304. Oversee procedures and deliverables for software verification. Investigate field complaints to ascertain root cause ... - May 15

Engineer: Manufacturing

Nanobiosym  –  Cambridge, MA
... Develops and implements validation protocols (IQ/OQ/PQ) that comply with FDA regulations. Conducts root cause analysis of product quality issues. QUALIFICATIONS S. or B.S. in Engineering (Plastics or Mechanical preferred) Six Sigma Black Belt, a ... - Jun 03

Food Safety and Quality Manager

The Judge Group  –  Haverhill, MA, 01832
... of Quality Management experience in food manufacturing Experience with sanitation oversight Strong knowledge of FDA/USDA/PCQI/SQF or BRC HACCP certification Strong leadership skills, excellent communication skills Experience managing a large team - May 31

Clinical Field Specialist

Access Vascular  –  Billerica, MA
... Our first product, FDA-cleared HydroPICC, has demonstrated an average of 97% less thrombus accumulation on its surface (based on platelet count)* compared to a standard polyurethane catheter. Access Vascular, Inc is a proud Equal Opportunity ... - Jun 08
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