10 days old

Senior Supplier Quality Engineer

Medtronic
Danvers, MA 01923
  • Job Code
    12716833
Position Description:
Sr. Supplier Quality Engineer for Medtronic, Inc located in Danvers, MA. Responsible for supplier coordination within the business, in support of selection and qualification of new suppliers or changes to existing supplied products and processes. Ensure conformance to purchased materials or finished devices requirements. Ensure supplier controls are in place and investigate supplier-caused nonconforming product and pursue corrective actions/improvements to prevent recurrence. Develop risk reduction or improved performance opportunities with supplier or design. Coordinate component qualification and/or process validation activities for new/existing purchased products. Perform quality system and/or process audits for initial supplier qualification and/or ongoing monitoring purposes. Coordinate Corrective and Preventive Action (CAPA) life cycle, Risk Mgmt. & Analysis, Supplier Controls, Process Validation, Product Acceptance Sampling, Approved Supplier List, Design of Experiments (DOE), Gage Repeatability & Reproducibility (Gage R&R) and Geometric Dimensioning and Tolerancing (GD&T). Responsible for failure investigation techniques, statistical quality control, protocol & report preparation and non-conforming product controls. Understand Extrusion, Injection Molding, Welding and Machining for medical devices. Leverage Good Manufacturing Practices (GMP). Navigate the complexities of various industry regulations to include FDA Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation, EU Medical Device Directive (EU MDD 93/42 EEC), Japan Pharmaceutical Affairs Law (JPAL) and ISO 13485 and ISO 17025.

Basic Qualifications:
Master's degree in Mechanical, Industrial or Biomedical Engineering and two (2) years of experience in quality engineering. Or Bachelors' degree in Mechanical, Industrial or Biomedical Engineering and four (4) years of experience in quality engineering. Must possess at least two (2) years' experience with the following: Supplier Quality Engineering in the medical device field; CAPA, Risk Mgmt. & Analysis, Supplier Controls, Process Validation, Product Acceptance Sampling, Approved Supplier List, DOE, Gage R&R, and GD&T; Failure investigation techniques, statistical quality control, protocol & report preparation and non-conforming product controls; Extrusion, Injection Molding, Welding and Machining for medical devices; GMP in medical device environment; and QSR 21 CFR 820, Canadian Medical Device Regulation, EU MDD 93/42 EEC, JPAL and ISO 13485 and ISO 17025.





Posted: 2022-08-02 Expires: 2022-08-31
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Senior Supplier Quality Engineer

Medtronic
Danvers, MA 01923

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