Senior Engineer, Quality Process
Stryker
Summary
Stryker is hiring a Senior Quality Engineer in Phoenix, Arizona, to support Sustainability Solutions. In this role, you will be responsible for analyzing and resolving production issues through collaboration with engineering and material procurement teams. You will perform monitoring of process data and analysis of trends, financial results, and customer feedback, and exhibit a commitment to quality first culture, compliance, and continuous improvement through projects that optimize production, inspection, and quality system processes.
Job description
What you will do
- Work closely with operations and business functions to ensure quality performance of product and processes
- Collaborate cross-functionally with internal and external teams to resolve quality issues
- Manage internal and supplier-driven Non-Conformances (NCs), ensuring timely investigation and closure
- Own Corrective and Preventive Actions (CAPAs) through root cause analysis to closure
- Disposition non-conforming product through MRB, issuing NCs as appropriate
- Initiate and lead development and improvement of manufacturing processes for existing and new products
- Review and approve change management activities, challenge change effectiveness and drive strong review
- Interpret KPI trends, act as necessary, and drive continuous improvement
- Support execution and analysis of manufacturing complaints and product field actions
- Provide QA support during internal and external audits
- Advocate Human Factor practices and be proficient in Human Factor identification and mitigation
- Apply risk management practices and concepts to manufacturing operations and identify opportunities and weaknesses
- Lead and participate in the Lean philosophy of standardization and waste elimination
- Understand Human Error Prevention and apply those principles to the manufacturing environment
- Support process/equipment validation, qualification, and Measurement System Analysis (MSA)
- Support product holds and execute containment plans
- Manage supplier relationships, including coordinating communications, monitoring performance, managing nonconformities, and ensuring timely delivery of quality materials and services
What you need
- B.S. in engineering or related discipline
- 2+ years as a Quality Engineer in a manufacturing environment
Preferred
- Proficient understanding of Med Device manufacturing processes, ISO 13485, GMP
- Lean Six Sigma training is a distinct advantage
- Excellent communication skills and attention to detail
- Proficient understanding of engineering and quality principles, including Risk Management, CAPA, Audits, and Statistics
- High level knowledge/experience of Risk Based and statistical techniques, particularly process risk, statistical sampling plans, Process Capability, Gauge R&Rs
- High level of PC skills; proficient with Microsoft Word, Microsoft Excel and PowerPoint
- Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired
- Strong knowledge of Quality Concepts (e.g., Risk Management, CAPA, Audits, Statistics)
- Confident representing Quality in cross-functional settings
- Self-starter able to manage multiple tasks in a fast-paced environment
- Willing to work as part of a multi-site team; some travel required
Requirements
- B.S. in engineering or related discipline
- 2+ years as a Quality Engineer in a manufacturing environment
- Proficient understanding of Med Device manufacturing processes, ISO 13485, GMP
- Lean Six Sigma training is a distinct advantage
- Excellent communication skills and attention to detail
- Proficient understanding of engineering and quality principles, including Risk Management, CAPA, Audits, and Statistics
- High level knowledge/experience of Risk Based and statistical techniques, particularly process risk, statistical sampling plans, Process Capability, Gauge R&Rs
- High level of PC skills; proficient with Microsoft Word, Microsoft Excel and PowerPoint
- Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired
- Strong knowledge of Quality Concepts (e.g., Risk Management, CAPA, Audits, Statistics)
- Confident representing Quality in cross-functional settings
- Self-starter able to manage multiple tasks in a fast-paced environment
- Willing to work as part of a multi-site team; some travel required
Company overview
Stryker is a global leader in medical technology, founded in 1941 by Dr. Homer Stryker and headquartered in Kalamazoo, Michigan. As one of the world's premier medical device companies, Stryker operates across three major business segments: Medical and Surgical Equipment, Orthopaedics and Spine, and Neurotechnology. The company impacts more than 150 million patients annually through its innovative products and services sold in over 75 countries worldwide. With approximately 53,000 employees globally and annual sales of $22.6 billion in 2024, Stryker maintains a strong commitment to research and development, investing $1.5 billion in R&D annually. The company's diverse portfolio includes surgical instruments, orthopedic implants, neurovascular devices, endoscopic systems, and advanced digital healthcare solutions. Stryker is recognized for its Mako robotic-assisted surgery systems and has been consistently ranked as one of Fortune's World's Best Workplaces for eight consecutive years, demonstrating its commitment to corporate culture and employee development.