Senior Quality Assurance Manager
4 weeks ago
About the Role
We are seeking a Senior Quality Engineer to drive major Quality improvement projects across functions. This position requires leadership skills to navigate government regulations and standards, including 21 CFR 820, ISO 13485 and ISO 14971.
Your Responsibilities Will Include:
- Provide Quality Engineering support for the Design Assurance team.
- Develop, modify, and maintain quality system (QMS) requirements.
- Collaborate with engineering and other functions to ensure quality requirements are met.
- 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.
Required Qualifications:
- 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).
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.
About Boston Scientific
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.
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