Software QARA Manager (Medical Device) Location: Northeast Salary is commensurate with experience >> Click here to apply online << Position Requirements include: BS degree in Computer Science or related fields. Minimum of 8 years experience in the Medical Device (software) industry with extensive knowledge in Quality Assurance, Service and Product Development. Demonstrated understanding of medical device regulations, [...]

IT Services QA/RA Specialist  Location: MA/RI/CT area Industry: Medical Devices – Software Imaging Salary is commensurate with experience >> Click here to apply online <<   Position Requirements include: • 5+ years of experience in QA/RA experience in medical devices. • Project management skills. • Knowledge of ISO 9001, ISO 13485, FDA, QSR, and ISO [...]

Post-Market QA/RA Specialist Location: MA/RI/CT area Industry: Class II Medical Devices Salary is commensurate with experience >> Click here to apply online <<   Position Requirements include: • 3-5 years of experience in medical device or pharmaceutical industry working in the areas of QA/RA, Project Management, Analyst, or Technical Support roles.  • Experience with quality management [...]

QA/RA Pre-Market Specialist  Location: MA/RI/CT area Industry: Medical Devices – Software Imaging Salary is commensurate with experience >> Click here to apply << Position Requirements include: • 5+ years of experience of QA/RA experience in medical device or pharma industries. • BSc. in Computer Science or related fields. • Strong design control experience. • Knowledge [...]

Quality Assurance Manager – Software Medical Devices Location: Midwest >> Click here to apply online <<     Position Requirements include: • Bachelors degree in Computer Science or related fields. • 8+ years of software QA management of medical devices. • Expertise in the following programming languages: C and C++. • Experience in Software V&V and [...]

Director of QA/RA Location: Danvers, MA            Salary: Commensurate with experience >> Click here to apply online << Position Requirements Include: Bachelors degree and preferably MBA 7-10+ years of experience in Class II Medical Device QA/RA and clinical affairs. 7+ years of experience in and FDA Regulatory (ISO, MDD, QSR, CAPA…) ISO 13485 Hands-on experience with 510k Medical Device application [...]

Regulatory Affairs Specialist Location: Danvers, MA            Salary: Commensurate with experience >> Click here to apply online << Position Requirements Include: 3-5 years of experience in Regulatory Affairs of Spinal medical device products B.Sc. in Engineering or related fields Experience in regulatory submissions, including 510(k), IDE, PMA Strong knowledge of the CFR 21 QSR, ISO 13485, [...]

Quality Assurance Engineer Location: Danvers, MA            Salary: Commensurate with experience >> Click here to apply online <<   Position Requirements Include: 3 years of experience in quality assurance of Class II medical device products B.Sc. in Engineering or related fields Experience with Orthopaedic Spinal medical device products Strong knowledge of the CFR 21 QSR, ISO [...]

VP of Quality Assurance & Regulatory Affairs Location: Bay Area, CA Click here to apply Position Requirements: Bachelors degree and preferably MBA 15+ years of experience in Medical Device QA/RA and clinical affairs. 10+ years of experience in and FDA Regulatory (ISO, MDD, QSR, CAPA…) ISO 13485 and 9000 Hands-on experience with 510k Medical Device [...]

Quality Assurance & Regulatory Affairs Compliance Manager Location: Northeast Salary: $125,000 + 10% bonus *Urgent need* To apply, please send resumes to Apply@ArkayCareers.com Job Summary: Our client is looking for a QA/RA compliance manager to lead and manage professionals to ensure a high level of Quality Management System and regulatory compliance in the facility. This [...]