Staff Advanced Quality Engineer

Work Flexibility: Hybrid

Stryker is hiring a Staff Advanced Quality Engineer to join our Sustainability Solutions team in Tempe, Arizona. In this role, you will partner with R&D Engineering and Advanced Operations throughout new product development, defining design requirements, developing manufacturing processes, and leading risk management activities to support product and process quality from development through launch.

What You Will Do

• Develop quality assurance documentation to support new product development and regulatory submissions.
• Lead risk management activities throughout product development, including evaluating residual risk and presenting final risk-benefit justifications to executive leadership.
• Partner with cross-functional teams to define design requirements and verification and validation testing, ensuring objective evidence supports established acceptance criteria.
• Collaborate with Advanced Operations to develop manufacturing processes and support product design transfers to internal and external manufacturing facilities.
• Apply statistical analysis and problem-solving techniques to establish product acceptance limits, define process parameters, analyze critical quality attributes, and resolve quality issues.
• Develop, review, and approve inspection plans, manufacturing documentation, and product drawings for new products.
• Evaluate quality issues from existing products and initial market feedback to identify potential risks and address concerns during new product development.
• Lead quality system improvements and provide technical direction to Quality Engineers and cross-functional project teams throughout design and process development.

What You Will Need

Required Qualifications

• Bachelor’s degree in Mechanical, Electrical, Chemical, Materials Science, Biomedical Engineering, or a related field.
• Minimum 4 years of experience in engineering.
• Experience applying quality concepts including corrective and preventive action (CAPA), audits, and statistical methods.
• Experience applying quality tools and problem-solving methods, such as Failure Mode and Effects Analysis, geometric dimensioning and tolerancing, root cause analysis, or mistake proofing.

Preferred Qualifications

• Master’s degree in an engineering or related technical field.
• Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), Six Sigma Green Belt, or Six Sigma Black Belt certification.
• Experience supporting product development in the medical device or another regulated industry, including areas such as risk management or design and process verification and validation.

USN: $89,300 - $148,800 USD Annual

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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.