Principal Quality Systems Engineer
About The Position
Minimum bachelor's degree in science and/or engineering 9+ years medical device/quality system experience (or a master's degree in science and/or engineering and 7+ years of medical device/quality system experience). Project management leadership: ability to create and manage a project through execution independently and ability work cross functionally to manage deadlines. Strong communication and presentation skills Understanding and working knowledge of applicable regulations and standards, including EU Medical Device Regulation (EU) 2017/745, ISO 13485, MDSAP, 21 CFR. Ability to develop effective, positive interpersonal relationships. Demonstrated competency working cross functionally and globally. Proficiency with Microsoft Office suite, including SharePoint. Experience with managing and updating notified body certificates. Experience working with notified bodies and audit support. Driven, energetic, self-assured professional with high personal integrity. Experience writing and implementing quality system procedures.
Requirements
- Minimum bachelor's degree in science and/or engineering 9+ years medical device/quality system experience (or a master's degree in science and/or engineering and 7+ years of medical device/quality system experience).
- Project management leadership: ability to create and manage a project through execution independently and ability work cross functionally to manage deadlines.
- Strong communication and presentation skills
- Understanding and working knowledge of applicable regulations and standards, including EU Medical Device Regulation (EU) 2017/745, ISO 13485, MDSAP, 21 CFR.
- Ability to develop effective, positive interpersonal relationships.
- Demonstrated competency working cross functionally and globally.
- Proficiency with Microsoft Office suite, including SharePoint.
- Experience with managing and updating notified body certificates.
- Experience working with notified bodies and audit support.
- Driven, energetic, self-assured professional with high personal integrity.
- Experience writing and implementing quality system procedures.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
