Head of Quality Assurance Medical Device

1 week ago


Billerica, Massachusetts, United States Sun Pharmaceutical Industries, Inc. Full time
Job Summary

We are seeking a highly skilled and experienced Head of Quality Assurance, Medical Device to join our team at Sun Pharmaceutical Industries, Inc. This is a critical role that requires a strong understanding of medical device regulations and quality management systems.

Responsibilities
  • Ensure all medical devices manufactured meet established specifications and comply with regulatory requirements.
  • Lead and/or support medical device regulatory inspections by FDA and Health Canada, corporate audits, and third-party audits.
  • Review and approve device history records related to medical devices.
  • Handle medical device-related complaints and ensure timely resolution.
  • Oversee the vendor/supplier management program and work closely with vendors to develop quality agreements.
  • Manage and maintain electronic Quality Management System (eQMS) data, EDMS for SOPs, and LMS for trainings.
  • Develop and implement quality improvement initiatives to ensure compliance with regulatory requirements.
  • Collaborate with cross-functional teams to ensure effective quality management.
Requirements
  • Bachelor'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), and CMDR (SOR/98-282).
  • Minimum 8-10 years of experience in Quality Assurance of Medical Device manufacturing environment.
  • Excellent communication and leadership skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.
What We Offer

As a member of our team, you will have the opportunity to work with a dynamic and experienced group of professionals who are passionate about delivering high-quality products. We offer a competitive salary, bonus target, and a comprehensive benefits package, including medical, dental, and vision coverage, life insurance, disability insurance, 401(k) savings plan, flexible spending accounts, and employee assistance program.

We are an equal employment opportunity employer and welcome applications from diverse candidates. If you are a motivated and experienced professional looking for a new challenge, please submit your application.



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