Manufacturing Quality Engineer

Category:
Engineering, Scientists & Technicians

Experience Level: Experienced

Work Arrangement:
Hybrid

Posting

Start Date:

10/22/26

Posting End Date: 11/5/26

We are looking for an experienced

Quality Engineer to join our team. In this hands-on role, you will provide quality engineering support for commercialized medical device manufacturing and help improve product and process performance. Your work will include investigating nonconformances, supporting product-quality decisions, improving yield and process capability, and maintaining quality and risk-management documentation. You will build deep technical knowledge while partnering across manufacturing, engineering, quality, supply chain, and regulatory to solve problems,make risk-based decisions, and drive sustainable improvements.

This position will be located at one of our facilities in Phoenix, Arizona, with the possibility of a hybrid remote work arrangement.

• Maintain quality engineering, risk-management, and design-control documentation to support product requirements and continued compliance with applicable global requirements
• Evaluate product and process nonconformances, providing risk-based recommendations for disposition and follow-up
• Lead structured problem-solving and root-cause investigations, developing and implementing effective corrective and preventive actions
• Apply engineering fundamentals, statistical analysis, and manufacturing data to support product-quality decisions and improve yield, capability, capacity, productivity, safety, and ergonomics
• Establish and improve sampling plans, visual standards, test methods, and other quality controls
• Support product and process changes, scale-up activities, test-method validation, and manufacturing validation
• Develop strong product and process knowledge to support investigations, risk assessments, change control, audits, and continuous improvement
• Collaborate with manufacturing, Quality Assurance, supply chain, regulatory, product specialists, and engineering partners to move work from problem identification through implementation
• Clearly document and communicate technical conclusions, risks, recommendations, and project status to technical and nontechnical stakeholders
• Contribute to an inclusive team environment where different perspectives are valued and used to achieve strong business and patient outcomes

• Bachelor’s degree in Engineering and a minimum of two years of relevant, post-graduate engineering experience in quality, process, product, or manufacturing engineering
• Experience applying a structured problem-solving approach, such as 8D, DMAIC, or PDCA, and root-cause analysis tools such as 5 Whys, why trees, or fishbone diagrams
• Working knowledge of product or process risk-management principles, including risk identification, analysis, mitigation, and documentation
• Ability to apply engineering fundamentals and statistical analysis to product-quality support, process optimization, and troubleshooting
• Ability to identify critical issues and failure modes, determine appropriate actions, and make sound, risk-based recommendations
• Demonstrated ability to organize and advance multiple projects or priorities against established timelines and deliverables
• Ability to work independently while building effective relationships and influencing cross-functional teams
• Ability to clearly document, communicate, and present technical work, conclusions, and recommendations
• Ability to travel up to 5%

• Experience in the medical-device industry or another regulated manufacturing environment
• Experience leading nonconformance investigations; including product disposition, root-cause analysis, risk-based conclusions, and updates to…