Engineer, Quality Process (Onsite)

Work Flexibility: Onsite

Stryker is hiring an Engineer, Quality Process, responsible for the analysis and resolution of production issues through collaboration with engineering and material procurement teams. Performs and monitors the process data and analysis of trends, financial results and customer feedback.

Candidate must reside within a commutable distance to Phoenix, Arizona and is expected to be onsite at the facility.

What you will do

• Lead 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.
• Work with Strategic Sourcing and Purchasing as the Supplier Quality resource.
• 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 to non-conforming inspection equipment and take action on affected product.
• 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 as required.
• Oversee all 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

• B.S. in engineering, or related discipline
• Quality Assurance knowledge and understanding.

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.

Travel Percentage: 0%

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.