Staff Quality Engineer - Onsite (Surgical Tech)

Regulatory Jobs; Kalamazoo (MI); On-site; USD 89,000 - 149,000; Full time

Job summary

Stryker Corporation in Kalamazoo, MI is seeking a Staff Quality Engineer to provide quality engineering support for new product launches and manufacturing transfers in Surgical Technologies. You will focus on quality assurance, process control, risk prevention, and continuous improvement of products and processes on site.

You will lead CAPA activities, investigations, and PPAP readiness, while collaborating with operations, engineering, supplier, and quality teams to ensure product and process

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.

Responsibilities

• 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 CAPA activities, including investigation, implementation, and effectiveness verification.
• Review and disposition nonconforming materials while supporting material review and quality decision-making processes.
• Execute PPAP activities and support manufacturing readiness for product and process changes.
• Support process validation, equipment qualification, MSA, and risk management activities.
• Monitor quality metrics, analyze trends using statistical methods and process control tools, and drive continuous improvement initiatives.

Skills

Quality mindset

Cross-functional collaboration

Regulated environment experience

Process improvement

Six Sigma belt

Education

Bachelor's degree in Engineering/Science

Tools

SPC

MSA

PPAP

CAPA

GD&T

ISO 13485

GMP

Job description

Stryker Corporation in Kalamazoo, MI is seeking a Staff Quality Engineer to provide quality engineering support for new product launches and manufacturing transfers in Surgical Technologies. You will focus on quality assurance, process control, risk prevention, and continuous improvement of products and processes on site.

You will lead CAPA activities, investigations, and PPAP readiness, while collaborating with operations, engineering, supplier, and quality teams to ensure product and process