Staff Quality Engineer

About the role

Stryker is seeking a Staff Quality Engineer to support product and process quality across manufacturing operations for its Instruments business in Portage, Michigan. The role works with operations, engineering, suppliers and quality teams to drive compliance, resolve quality issues, support new product introductions and manufacturing scale-up, lead continuous improvement and ensure products meet regulatory and quality requirements. The position is onsite.

Key responsibilities

• Monitor and improve product and process quality performance with manufacturing, engineering and quality teams.
• Support the transfer, launch and scale-up of new products and processes, establishing robust quality systems and ensuring production readiness.
• Lead investigations and timely closure of non-conformances and corrective and preventive actions, including root cause analysis and corrective actions.
• Review and dispose of nonconforming materials and products through Material Review Board processes.
• Collaborate with suppliers on quality issues, manage supplier corrective actions and support supplier quality improvement.
• Evaluate manufacturing, supplier and engineering changes for quality and regulatory compliance.
• Monitor quality performance indicators, analyse trends and act on risks and improvement opportunities.
• Lead or support continuous improvement focused on quality, scrap reduction, efficiency and cost savings.
• Support process validation, equipment qualification, inspection methods, measurement system analysis and statistical process control.
• Participate in internal and external audits, complaint investigations, field actions and continuous improvement projects.

Required profile

• Bachelor's degree in Engineering, Science or a related technical discipline.
• Minimum 4 years of quality engineering, manufacturing engineering or related engineering experience.
• Experience supporting non-conformance investigations, corrective and preventive actions or quality management systems.

Preferred qualifications

• Medical device industry experience.
• Quality data analysis and statistical methods applied to manufacturing or process improvements.
• Six Sigma Green Belt or Black Belt certification.
• Geometric dimensioning and tolerancing (GD&T) experience.
• Metrology equipment such as calipers, micrometers, pin gauges or CMMs.

Pay range: $89,300 - $148,800 USD per year; travel of 20%.