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    Senior Staff Engineer, Quality Assurance - Kalamazoo, United States - Stryker

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    Description

    Work Flexibility:
    OnsiteStryker is hiring a Senior Staff QA Engineer for our Global Quality Operations team in Kalamazoo, MI.Who we want
    • Analytical problem solvers.
    People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
    Dedicated achievers.

    Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

    Collaborative partners.

    People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

    What you will do
    • Work closely with operations and the business functions to ensure quality performance of product and processes.
    Collaborates with Divisional QA, cross-functional and suppliers' teams to address top quality issues. Own identified internal and supplier driven non-conformances and manage the timely closure of nonconformances within. Own or support identified internal CAPAs and manage to timely root cause investigation, implementation and closure. Disposition non-conforming product within MRB, issuing nonconformances as appropriate. Communicate with suppliers regarding non-conformances, escalating supplier corrective action requests as required.
    Engage in the development and improvement of the internal manufacturing processes for existing products.
    Performs critical assessment of internal and supplier proposed change management activities.
    Participates in the creation and/or review of new or modified procedures.

    Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.

    Support execution and analysis of manufacturing related complaints and product field actions.
    Advocate of Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.
    Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification. Develop understanding of risk management practices and concepts and applies knowledge to manufacturing operations.
    Support the creation and maintenance of inspection methods and sampling. Applies statistical methods of analysis and process control to current operations.
    Engage and interface in internal and external audits providing subject matter expertise.
    Support the development and review of process and equipment validation/qualification and MSA of internal processes.
    Execute internal quality deliverables associated with engineering changes, manufacturing transfers and supplier-initiated changes. Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.

    Responsible for initiation, internal containment, communication and support of Commercial Holds for potential product escapesWhat you need:
    Bachelor of Science or in an Engineering discipline required.6+ years' experience in a manufacturing or quality environment required.
    Knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).Able to demonstrate strong communication, project management and ability to influence without authority. Able to demonstrate the ability to manage multiple tasks simultaneously.
    Ability to represent Quality function with project teams.
    Strong interpersonal skills, written, oral communication and negotiations skills.
    Strong in critical thinking and "outside the box" thinking.
    Highly developed problem-solving skills. Strong analytical skills.
    Demonstrated ability to successfully manage and complete projects in a matrix organization.
    Demonstrated ability to work independently and as part of cross-functional teams.


    Travel Percentage:
    20%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.

    Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

    However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.



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