• Senior Staff Engineer, Quality Systems

    Stryker (Salt Lake City, UT)


    **Stryker** is hiring a **Senior Staff Quality Systems Engineer** for our Quality Management Systems (QMS) team to support and manage Supplier Quality activities within our **Neurovascular** division who will be responsible for ensuring an effective and efficient quality management system is built and maintained.

    What you will do:

    + Lead in developing optimum future state of the QMS processes for business needs, aligned with Corporate

    + Develop & deliver training and coaching for new QMS users on QMS principles and on the applicable systems

    + Lead auditor capable of ensuring compliance with the appropriate internal & external regulatory requirements, (including but not limited to Division, Corporate, FDA, ISO, MDD, and individual country regulatory requirements)

    + Co-ordinates external consultants to perform supplier audits

    + Understands Quality Systems & web-based interactions.

    + Key contributions to the business process(es) and understands how IT systems support those business processes.

    What you need:

    Required:

    + Bachelor’s degree

    + Minimum of 6 years in Quality or Regulatory Affairs environment with 3 years’ experience within the area of Quality Management Systems.

    + Experience in Quality Systems (e.g. CAPA, Audits, Management review, Quality Planning)

    + Experience working as a Supplier Quality Engineer in a Medical Device regulated environment required.

    + Experience in interacting with regulatory agencies (FDA, BSi, etc.).

    Preferred:

    + Bachelor’s degree in science or engineering

    + Lead Auditor Certified and/or Lean Six Sigma Qualification

     

    Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

     

    Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.