Engineer, Quality Process (Onsite)

Work Flexibility: Onsite

Stryker is hiring an Engineer, Quality Process, in Chandler, Arizona to support Stryker's Sustainability Solutions (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.

Travel Percentage: 10%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 contractors legal duty to furnish information.