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Full-time Sr. Quality Engineer

at Jobisite in Minnesota

Title: Sr. Quality Engineer
Location: Fridley, MN
Duration: 6+ months

Job Description:

• Review, process and approve supplier change notices
• Write and execute Qualification protocols and reports for released and development products
• Coordinate with Receiving Inspection to conduct Qualification testing
• Present and obtain approval of Change Control Plans and Reports from Neuromodulation’ s Change Control Board
• Interface with Medtronic incoming inspection employees and review inspection procedures
• Review and approve supplier documentation
• Participate in Supplier Management Review activities
• Coordinate with Regulatory partners to ensure proper Regulatory review and approval of changes
• Perform or coordinate test method validation on Receiving Inspection test methods at Medtronic and at suppliers
• Conduct statistical analysis of variables data and present in Qualification reports
• Own and update Qualification procedures and other departmental procedures
• Apply QSR 21 CFR Part 820 (Medical Devices) to everyday application of Supplier Quality Engineering activities.
• Initiate and maintain appropriate corrective and preventive action per defined procedures

Primary Skills:

Bachelor’s degree in Engineering with 6+ years of experience.
Medical Device experience, familiar with Medical Device Regulations such as ISO 13482 and 21CFR820.
Quality experience managing and qualifying Finished Device manufacturers.
EDUCATION REQUIRED:
Bachelors of Science Degree

YEARS OF EXPERIENCE
6+ years of experience in quality or other related engineering field

DESIRED/PREFERRED QUALIFICATIONS

• Understanding of quality principles, procedures, methodologies, and basic statistics
• Knowledge of statistical analysis techniques
• Knowledge of DMAIC problem solving methodology
• Project Management experience
• Knowledge of Finished Device Medical manufacturers processes

Secondary Skills

• ASQ Certification in Quality or Reliability.
• Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1 and MDD.
• Working knowledge of hardware development for medical devices.
• Ability to author technical reports, business correspondence and standard operating procedures.
• Ability to apply knowledge and work with development and supply vendors to ensure compliance to Medtronic requirements.
• Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchical levels in the organization.
• Ability to multi-tasks, prioritize, meets/exceed deadlines and hold themselves, and others accountable.
• Self-Starter with a sharp focus on quality and customer experience.

Any specific industry experience
Medical

Education
BS / MS




Reference : Sr. Quality Engineer jobs


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Published at 19-06-2019
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