Sr Quality Systems Manager
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BASIC QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE:
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.
SPECIALIZED KNOWLEDGE/SKILLS REQUIRED:
- 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
DESIRED/PREFERRED QUALIFICATIONS (optional):
- 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
PHYSICAL JOB REQUIREMENTS: The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.
ALSO Required:
- 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%
