Principal Quality Engineer-Medical Device-Diabetes business

Medtronic - Northridge CA

Posted 590 days ago
  • Experience
    Mid-Senior level
  • Job function
    Engineering
  • Employment type
    Full-time
  • Industry
    Medical Devices, Pharmaceuticals, Defense & Space
  • Employer job ID
    85892
  • Job ID
    4836427

This is a preview of the Principal Quality Engineer-Medical Device-Diabetes business job at Medtronic. To view the full job listing, join LinkedIn - its free!Join LinkedIn - its free!

About this job

Job description

Manage and plan quality programs to ensure the quality and reliability of Medtronic Diabetes products. Track international standards and guidelines from pre-publication through harmonization and will manage the process of implementing these standards through thequality system.

 

Assure timely, accurate and independent evaluation of product performance and compliance to safety and regulatory requirements prior to manufacturing and market release.

Work with Manufacturing to direct, coordinate & monitor the production processes that are in compliance to FDA QSR, ISO 13485 and other applicable regulatory requirements (JPAL, Canada, etc.); and to ensure that safe and effective products are produced.

Support product and process validations by applying manufacturing quality toolset including but not limited to: FTA, FMEA, DFEMEA, PFMEA, IQ, OQ, PQ, analysis, control plans, process verification/validation plans, validation protocol development, Cpk, Cp, SPC, DOE, process data analysis, and DMAIC.

Work closely with R&D to develop appropriate verifications (DVT), validations (software, process), and qualifications (subcontractors, system and subsystems), for both new design and changes to released product. Work in product development teams to ensure provisions for quality are addressed and resolved prior to release.

Coordinate with the development of essential design control deliverables including, but not limited to, product performance analysis on similar products, essential requirements checklist, product specifications, risk analysis, failure mode and effects analysis, fault tree analysis, design verification / validation, design reviews, phase reviews, and product release authorization for distribution of product.

Review design inputs (specifications) and design outputs (reports, drawings, etc.) to assure that appropriate design requirements are specified and to evaluate/confirm quality requirements prior to successful design transfer.

Review & approve product verification and validation plans and reports and engineering change requests.

Participate in complaint investigations and failure analysis of returned products; document findings and provide reports and analysis to CAPA bodies (QIT & CIT). Compile & institute quality metrics to trend, recommend and implement corrective action and appropriate follow-up.

 

QUALIFICATIONS:  BS Engineering or Science-related field and 7+ yrs experience in Quality Assurance and/or Quality Engineering including 2+ yrs experience in medical device, bio-medical or other regulated industry (e.g. pharma, defense, aerospace, automotive).
• Hands on experience in pFMEA, dFMEA, risk analysis and management
• Working knowledge of ISO quality system (ISO13485), USFDA Quality System Regulation
• Working knowledge of problem solving and statistical methods as applied to process and product quality.

Desired Skills and Experience

MS Degree in Engineering (Electrical, Biomedical, Mechanical or equivalent).
• More than 7 years’ related experience in Quality Assurance and/or Quality Engineering in a regulated environment.
• More than 2 years’ experience in bio-medical or other regulated industry.
• Certified Lean or Six Sigma Black Belt.
• Project Management experience.
• Experience working with remote suppliers and facilities, both domestic and international.
• ASQ certification in Quality, Reliability or Software QA.
• An ability to interact with senior external personnel on significant technical matters often requiring coordination between organizations.
• Guide the successful completion of major programs and an ability to perform in a leadership role.

About this company

Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, Minnesota USA is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic's mission is:
* To contribute to human welfare by application of biomedical engineering in the research, design, manufacture, and sale of instruments or appliances that alleviate pain, restore health, and extend life.
* To direct our growth in the areas of biomedical engineering where we display maximum strength and ability; to gather people and facilities that tend to augment these areas; to continuously build on these areas through education and knowledge assimilation; to avoid participation in areas where we cannot make unique and worthy contributions.
* To strive without reserve for the greatest possible reliability and quality in our products; to be the unsurpassed standard of comparison and to be recognized as a company of dedication, honesty, integrity, and service.
* To make a fair profit on current operations to meet our obligations, sustain our growth, and reach our goals.
* To recognize the personal worth of employees by providing an employment framework that allows personal satisfaction in work accomplished, security, advancement opportunity, and means to share in the company's success.
* To maintain good citizenship as a company.

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