• Engineer, Quality Process

    Stryker (Chandler, AZ)


    Stryker is hiring an **Engineer, Quality Process,** in **Chandler, Arizona** to support Stryker's Sustainability Solutions (http://sustainability.stryker.com/) (SSS)! In this role, you will be responsible for analyzing and resolving production issues by collaborating closely with engineering and material procurement teams. You will also monitor process data, analyze trends, evaluate financial results, and incorporate customer feedback to drive continuous improvement.

    What you will do:

    + Conduct the implementation and maintenance of systems ensuring global regulatory compliance.

    + Perform robust root cause analysis of production issues, implement appropriate containment, and drive corrective action.

    + Monitor / analyze production performance trends for key quality metrics and establish appropriate control measures.

    + Drive detection and prevention of non-conformances to improve business results through reductions in scrap and rework costs in addition to assurance of a positive customer experience.

    + Evaluate and improve quality inspection methods and fixtures to improve reliability and repeatability of incoming, in-process, and final QC.

    + Analyze the risk associated with non-conforming inspection equipment and take action on affected products.

    + Identify and lead implementation of process / procedure / system improvements. For example, component qualification process, skip lot process, supplier change process, etc.

    + Partner with Operations and Division engineering to develop solutions to non-conformances.

    + Provide support during internal and external audits.

    + Oversee post-market reporting, including Medical Device Reporting (MDR) and Medical Device Vigilance (MDV).

    + Maintain up-to-date knowledge of global regulatory requirements for adverse event reporting.

     

    What you will need

    Required:

    + B.S. in engineering, or related discipline. Biomedical strongly preferred.

    + 0+ experience in Quality Assurance or engineering.

    Preferred:

    + Ability to train Technical Service and Support teams on compliance with post-market surveillance requirements.

    + Ability to collaborate with key partners to ensure global policy adherence and process improvements.

    + Provide strategic planning and tactical direction to meet quality objectives and predefined metrics.

     

    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.