Wimmer Solutions
Head of QA (Medical Device)
Wimmer Solutions, Billerica, Massachusetts, us, 01821
HEAD OF QA - MEDICAL DEVICEBillerica, MA (Onsite)22814Our client is looking for a
Head of QA
who will be responsible for all aspects of QA for Medical Device and combination products manufactured either on site or at third party contract manufacturer. You will also be ensuring all medical devices manufactured meet established specifications.WHAT YOU GET TO DOEnsure compliance of establish Quality Management System (QMS) and in compliance with corporate requirements and all applicable FDA Part 4, Part 210/211, Part 820, ISO 13485 and Canadian Medical Devices Regulations (CMDR SOR/98-282), EU Medical Device Regulation 2017/745. Ensure site readiness for regulatory agency inspections and/or Sun Corporate Audits.WHAT YOU BRINGBachelor's degree in Science or related scientific fields.Strong knowledge of medical device regulations including 21 CFR 4, 21 CFR 210/211, 21 CFR 820, ISO 13485, EU MDR (2017/745), CMDR (SOR/98-282).Experience in working directly with FDA.Demonstrated ability to lead QA medical device and combination products compliance and auditing operations, make sound decisions regarding evaluation of cGMP compliance, and leadership ability.Demonstrated understanding and deployment of modern root cause and problem-solving techniques such as statistical process controls and quality function deployment.Excellent understanding of medical device QA principles, industry practices, and standards.Must be able to work for a US based company without requiring visa sponsorship.COMPENSATION AND BENEFITSSalary range is between $120k to $140k based on experience and qualifications, as well as geographical market and business considerations.+10% bonus3 weeks paid vacation401(k) match
Head of QA
who will be responsible for all aspects of QA for Medical Device and combination products manufactured either on site or at third party contract manufacturer. You will also be ensuring all medical devices manufactured meet established specifications.WHAT YOU GET TO DOEnsure compliance of establish Quality Management System (QMS) and in compliance with corporate requirements and all applicable FDA Part 4, Part 210/211, Part 820, ISO 13485 and Canadian Medical Devices Regulations (CMDR SOR/98-282), EU Medical Device Regulation 2017/745. Ensure site readiness for regulatory agency inspections and/or Sun Corporate Audits.WHAT YOU BRINGBachelor's degree in Science or related scientific fields.Strong knowledge of medical device regulations including 21 CFR 4, 21 CFR 210/211, 21 CFR 820, ISO 13485, EU MDR (2017/745), CMDR (SOR/98-282).Experience in working directly with FDA.Demonstrated ability to lead QA medical device and combination products compliance and auditing operations, make sound decisions regarding evaluation of cGMP compliance, and leadership ability.Demonstrated understanding and deployment of modern root cause and problem-solving techniques such as statistical process controls and quality function deployment.Excellent understanding of medical device QA principles, industry practices, and standards.Must be able to work for a US based company without requiring visa sponsorship.COMPENSATION AND BENEFITSSalary range is between $120k to $140k based on experience and qualifications, as well as geographical market and business considerations.+10% bonus3 weeks paid vacation401(k) match