Quality Assurance Lead for Medical Devices
1 week ago
About the Role:
We are seeking a Quality Assurance Lead to drive quality improvement projects across functions. This position requires leadership skills and expertise in medical device design controls.
Key Responsibilities:
- Provide quality engineering support for the Design Assurance team.
- Navigate government regulations and standards, including 21 CFR 820, ISO 13485, and ISO 14971.
- Develop, modify, and maintain quality system (QMS) requirements.
- Collaborate with engineering and other functions to ensure quality requirements are met.
- Collaborate with Research & Development (R&D) Engineers to update Design History Files (DHFs) and meet new requirements.
- Provide quality and compliance input to project teams for project decisions and deliverables, especially those related to risk.
- Support internal and external audits as required.
Requirements:
- Bachelor's degree in engineering required.
- 4-5 years of medical device experience, or advanced degree with a minimum of 3 years medical device experience.
- A strong understanding of medical device design controls.
- Must be a critical thinker and active listener with good time management skills.
- Self-starter with the ability to quickly learn about new processes.
- Excellent analytical and communication skills (written and oral).
- Ability to work effectively within a team and across functions.
Preferred Qualifications:
- Experience working in a quality role at a medical device company.
- Experience working with PLM (Windchill) and ERP (MES and/or SAP) software.
- Experience with quality system integration.
- Experience with DHF remediation projects.
About Boston Scientific:
Boston Scientific is a leader in medical science for over 40 years, committed to solving challenges that matter most. We are united by a deep caring for human life and strive to advance science for life through innovative medical solutions.
Salary Range:$120,000 - $150,000 per year
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