Goodluck123
Iselin, NJ
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Job Description :
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
             

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