• Senior Quality Manufacturing Engineer

    Stryker (San Jose, CA)


    Stryker is hiring a Senior Quality Manufacturing Engineer in San Jose, CA, to enhance and sustain quality standards in repair processes for medical products. In this role you will focus on improving procedures, collaborating with suppliers, and supporting compliance with regulatory standards while driving cost and efficiency improvements.

    What you will do:

    + Identify and lead implementation of procedure, process improvements of responsible repair lines.

    + Communicate and collaborate with suppliers to solve product and component quality issues.

    + Trend key quality metrics and proactively takes action as needed.

    + Independently review, trend, and process nonconformances for responsible product and components.

    + Troubleshoot product quality issues of moderate complex scope where the analysis requires a variety of factors.

    + Own NCs/CAPAs for responsible product and support overall team in implementation of robust corrective and preventative actions.

    + Ensure compliance of documentation for inspection/testing and repair procedures.

    + Train repair technicians on repair processes and procedure changes.

    + Responsible for processing supplier-initiated requests and necessary supporting documentation.

    + Partner with repair technicians and supervisors to ensure processes and equipment can meet demand requirements.

    + Drive continuous improvement actions/initiatives with suppliers and in-house teams to reduce quality issues, increase performance, reduce lead time, reduce cost, etc.

    + Execute moderately simple validation of equipment

    + Provide input in the new product development process by using current generation data to identify effective and efficient repair techniques.

    + Support Service in internal and external audits (FDA and Notified Body auditors).

    + May interact with customers to solve reliability issues and/or answer general product questions.

    What you will need:

    Required:

    + Bachelor’s Degree in a technical field

    + 2+ years of relevant full time experience

    Preferred Qualifications:

    + Bachelor’s in Engineering

    + Knowledge of applicable domestic and international regulations and quality system standards – FDA QSR, MDD, ISO13485, ISO9001, etc.

    + Experience with Non-Conformances and Corrective and Preventative Actions

    + Ability to express ideas and collaborate effectively with multidisciplinary teams.

    + Experience in independently executing moderately complex problem-solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design.

    + Solid analytical skills, ability to plan, organize and implement concurrent tasks.

    + Demonstrated mechanical/electrical problem-solving skills.

    + Proven ability to handle multiple assignments at once while meeting all deadlines.

    + Must be able to routinely make decisions which affect immediate operations.

    + Demonstrated ability to plan, track and facilitate projects.

    + Understanding of Quality Management System tools, Six Sigma tools, problem solving, root cause analysis, Lean and continuous improvement methodologies, with proven ability to apply them.

     

    $100,400 - $160,800 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

     

    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.