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Principal Quality Systems Engineer at Boston Scientific Corporation Malaysia
Arden Hills, Minnesota, United States -
Full Time

Start Date

Immediate

Expiry Date

07 Apr, 26

Salary

0.0

Posted On

07 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Project Management, Communication Skills, Presentation Skills, Regulatory Knowledge, ISO 13485, MDSAP, 21 CFR, Interpersonal Relationships, Cross Functional Collaboration, Microsoft Office, SharePoint, Audit Support, Quality System Procedures, Medical Device Experience, Quality System Experience, Notified Body Management

Industry

Medical Equipment Manufacturing

Description
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.
Responsibilities
The Principal Quality Systems Engineer will lead projects through execution and manage deadlines while working cross-functionally. They will also be responsible for writing and implementing quality system procedures.