Staff Quality Engineer
Stryker
Summary
As a Staff Quality Engineer in Kalamazoo MI, you will provide quality engineering support for quality deliverables related to new product launches and manufacturing transfers for Surgical Technologies. This includes supporting projects throughout the full lifecycle, as well as post-handoff manufacturing sustainment activities, with a focus on quality assurance, process control, risk prevention, and continuous improvement of products and manufacturing processes. Additionally, you will support supplier quality issues that impact projects, lead initiatives to enhance product and process quality, and ensure compliance with applicable regulatory requirements and quality standards.
Job description
What You Will Do
- Support quality deliverables for new product launches, manufacturing transfers, supplier changes, and engineering change initiatives.
- Partner with operations, engineering, supplier, and quality teams to ensure product and process quality performance.
- Own nonconformance investigations and drive timely containment, root cause analysis, corrective actions, and record closure.
- Lead and support Corrective and Preventive Action (CAPA) activities, including investigation, implementation, and effectiveness verification.
- Review and disposition nonconforming materials while supporting material review and quality decision-making processes.
- Execute Production Part Approval Process (PPAP) activities and support manufacturing readiness for product and process changes.
- Support process validation, equipment qualification, measurement system analysis (MSA), and risk management activities.
- Monitor quality metrics, analyze trends using statistical methods and process control tools, and drive continuous improvement initiatives.
What You Will Need
Required Qualifications
- Bachelor’s degree in Engineering, Science, or a related technical field
- Minimum 4 years of experience in quality engineering, manufacturing quality, supplier quality, or a related quality-focused engineering role
- Experience leading or supporting cross-functional quality projects, including new product launches, manufacturing transfers, process improvements, or engineering change initiatives in a regulated environment.
Preferred Qualifications
- Experience with quality systems, including nonconformance management, CAPA, audits, and risk management.
- Experience supporting process validation, equipment qualification, PPAP, and measurement system analysis (MSA).
- Familiarity with statistical process control (SPC), data analysis, and quality improvement methodologies.
- Familiarity with geometric dimensioning and tolerancing (GD&T).
- Experience using metrology equipment such as calipers, micrometers, pin gauges, and coordinate measuring machines (CMMs).
- Familiarity with ISO 13485 and Good Manufacturing Practice (GMP) requirements.
- Six Sigma Green Belt or Black Belt certification.
Requirements
- Bachelor’s degree in Engineering, Science, or a related technical field
- Minimum 4 years of experience in quality engineering, manufacturing quality, supplier quality, or a related quality-focused engineering role
- Experience leading or supporting cross-functional quality projects, including new product launches, manufacturing transfers, process improvements, or engineering change initiatives in a regulated environment
- Experience with quality systems, including nonconformance management, CAPA, audits, and risk management
- Experience supporting process validation, equipment qualification, PPAP, and measurement system analysis (MSA)
- Familiarity with statistical process control (SPC), data analysis, and quality improvement methodologies
- Familiarity with geometric dimensioning and tolerancing (GD&T)
- Experience using metrology equipment such as calipers, micrometers, pin gauges, and coordinate measuring machines (CMMs)
- Familiarity with ISO 13485 and Good Manufacturing Practice (GMP) requirements
- Six Sigma Green Belt or Black Belt certification
Benefits
- 401(k) Matching
- Medical, Dental & Vision
- Paid Time Off
- Travel 20%
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.