Sr Quality Systems Manager
EDUCATION and/or EXPERIENCE:
- Bachelor's Degree
- 7+ years' work experience including 5+ or more years of relevant quality system experience in a medical device manufacturer
- 5+ years of experience providing work direction and leadership to people and teams.
- Previous experience with ISO/CE certification process.
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Previous experience with US and international medical device regulations
- Excellent communication skills, both oral and written
- Effective interaction with personnel at diverse positions within and outside of the organization
- Strong communication and organization skills
- Ability to prioritize and meet deadlines for multiple projects
- Engineering Degree
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Previous experience the management of FDA Inspections
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Previous experience the management complex Quality System implementation projects
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Previous experience in Supply Chain or Distribution Quality
- Master's degree
- Professional Quality Certification (e.g., ASQ CQE, CRE, or CQA)
- In-depth knowledge of the following: AATB, CMDCAS, PAL, ISO 13485, ISO 14971, MOD 93/42 EEC, and CFR 21 Part 820
- Must be able to travel independently to various Medtronic buildings/sites including internationally.
- The noise level in the work environment is usually quiet to moderate.
- The employee frequently is required to stand; walk; and use hands to finger, handle, or feel objects, tools, or controls.
- The employee is occasionally required to reach with hands and arms.
- The employee must occasionally lift and/or move up to 15 pounds.
- Specific vision abilities required by this job involve normal vision.
- Travel up to 25%