11 days old

Sr. Operations Quality Engineer

Medtronic
Irvine, CA 92606
  • Job Code
    20000AB8

Position Description:
Sr. Operations Quality Engineer , Covidien LP (a Medtronic company), Irvine, CA. Multiple positions available . Provides quality engineering support to ensure the successful development of Medtronic Neurovascular products. Ensure design control requirements are met and products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements. Works with vascular devices, embolic coils, stents, catheters, balloons, aspiration devices, coatings and guide wires to ensure quality products. Navigates various government and industry standards to include FDA 21CFR part 820, ISO13485, ISO14971 and Good Manufacturing Practices (GMP). Coordinates risk activities using PFMECA and DFMECA and other risk management tools. Provides Process Verification & Validation for product quality, including development and execution of protocols (IQ, OQ, PQ) and test methods (TMV). Coordinates root cause investigations using various quality tools (5 Whys, 6 M, Ishikawa Diagram, Pareto Charts). Utilizes lean six sigma and lean principles to make manufacturing and efficiency improvements including DOE (Design of Experiment). Participates in and leads CAPA and NCMR root cause investigation/determination and implementation of corrective and preventive actions as necessary. Utilizes statistical analysis tools including process capability and measurement system analysis, and tolerance interval analysis with proficiency in Minitab. Designs and manufactures documentation to include specifications, procedures and sampling methods as well as being proficient in engineering drawing and GD&T. Shift support may vary.

Basic Qualifications:
Master's degree in Biomedical Engineering, Mechanical Engineering, Industrial Engineering, Industrial Engineering Management or related field and two (2) years of experience in medical device quality engineering. Must possess at least 2 years' experience with each of the following: FDA 21CFR part 820, ISO13485, ISO14971, and Good Manufacturing Practices (GMP); Risk activities using DFMECA and PFMECA and risk management tools; Process Verification & Validation; development and execution of validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ); Test method development and validation (TMV); Root cause investigations using various quality tools including 5 Whys, 6 M, Ishikawa Diagram, and Pareto Charts; Six sigma and lean principles including DOE (Design of Experiment); CAPA (corrective and preventive actions) and NCMR (non-conforming material report) investigation and corrective action implementation; statistical analysis tools including process capability and measurement system analysis, and tolerance interval analysis with proficiency in Minitab; design and manufacturing documentation to include specifications, procedures and sampling methods; and engineering drawing and GD&T. Shift support may vary.





Posted: 2020-06-29 Expires: 2020-07-28
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Sr. Operations Quality Engineer

Medtronic
Irvine, CA 92606

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