Advanced Quality Engineer

Work Flexibility: Hybrid or Onsite

Stryker is hiring an Engineer, Advanced Quality Engineering for our Sustainability Solutions team supporting our reprocessing product line. You will be a key member of the new product development team ensuring the implementation of cutting-edge technology for medical devices is safe, effective, and compliant with industry practices. Working closely with R&D, Marketing, Advanced Operations, and Regulatory Affairs team members, you will be in a fast-paced environment with opportunities to win for yourself, the company, and patients around the world.  This position is a hybrid between a traditional R&D Engineer and a traditional Quality Engineer.

Workplace Flexibility: Candidate must reside within a commutable distance to Tempe, AZ and is expected to be onsite 3+ days/week at the facility and is not eligible to be fully remote.

What you will do:

• Represents Quality Assurance on New Product Development (NPD) cross-functional teams, collaborating with R&D, Regulatory Affairs, Advanced Operations, and Marketing to meet product development metrics.

• Supports Risk Management activities, including creating and implementing Risk Management Files, identifying hazards, and ensuring compliance with corporate and local design control procedures.

• Plans, designs, and implements inspection, testing, and evaluation methods to ensure product and production reliability, applying advanced statistical techniques for test sample size determinations.

• Supports Design Reviews to ensure design and process robustness, compliance with applicable regulations (e.g., QSR, ISO 13485), and proper risk analysis for new medical devices.

• Plans, performs, and reviews engineering risk analyses, test methods, and process improvements to enhance product quality and manufacturing efficiency.

• May interact with customers to address product quality concerns, provide training on quality assurance and GMP topics, and support continuous improvement initiatives.

What you will need:

Required:

• Bachelor's degree in Mechanical, Electrical, Chemical, Material Science, Biomedical Engineering or related Science or engineering discipline

Preferred:

• Experience in data collection, data analysis, and scientific method.

• Experience with Quality Concepts such as Risk Management, CAPA, Audits, Statistics.

• Previous medical device industry experience preferred 

• Understanding of US and International Medical Device Regulations, including ISO 13485, GDP, GMP.

  

 

$76,500 - $122,000 USD Annual

  

 

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 contractor’s legal duty to furnish information.