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Senior Supplier Quality Engineer

PlymouthMedtronic



The Senior Supplier Quality Engineer Perform Supplier Quality Engineering activities including audit, performances evaluation and supplier development. This person must also ensure these activities are accomplished in compliance with applicable industry/regulatory standards and company quality objectives.




Position Responsibilities

  • Provide Engineering support to Sourcing team in support of Supplier Performance Management

  • Lead or participate in the audit/assessment of current or future suppliers ensuring they are compliant with associated Medtronic policies and ISO 13485 Quality System requirements

  • Identify and manage risk throughout the supplied material process with the use of risk management tools. This includes incorporating elements from the design process and working with the manufacturing department to ensure material requirements are correctly identified for and met by suppliers.

  • Manage supplier change notification program through risk based evaluation

  • Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested

  • Assist with the analysis and resolution of design or manufacturing material issues as these arise

  • Contribute to material design input requirements from experience with previously reported problems, Covidien products, competitive devices and/or other similar products

  • Participate in supplier selection process and specification reviews with suppliers to ensure that purchased components/materials meet Medtronic specifications

  • Specify quality characteristics and inspection plans for components, subassemblies, and finished devices

  • Evaluate and disposition supplier caused non-conformances and drive risk based corrective action to prevent recurrence

  • Own various individual Product and Process quality system procedures relating to supplier performance management

  • Supervise and/or train and develop junior Supplier Quality Engineers in Quality Assurance methods

  • Comply with applicable FDA and international regulatory laws/standards and the Medtronic Guide to Business Conduct

  • Other duties as assigned or required

    IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME:

    REQUIRED EDUCATION:

  • Bachelor's Degree in Engineering or Science

    REQUIRED YEARS OF EXPERIENCE:

  • 5+ years of experience in Supplier Quality Engineering in the Medical Device or Pharmaceutical industry

    SPECIALIZED KNOWLEDGE REQUIRED:

  • Demonstrated skills in decision making




    DESIRED/PREFERRED QUALIFICATIONS AND SPECIALIZED KNOWLEDGE:

  • Previous supervisory experience

  • Demonstrated skills in decision making across a broad spectrum of Quality Engineering responsibilities

  • ASQ Quality Engineering certification

  • Leading supplier quality engineering, training and compliance teams

  • Facilitation of internal/external audit experience




    PHYSICAL JOB REQUIREMENTS:

    The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • While performing the duties of this job, the employee is regularly required to be independently mobile.

  • The employee is also required to interact with a computer for extended periods of time, and communicate with peers and co-workers.

  • Must be able to travel to Supplier locations.

  • Must be able to travel 25% of the time.

    ABOUT MEDTRONIC:

    Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

    We can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

    It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

    This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees

    The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

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