Senior Quality Engineer

Stryker; Kalamazoo (MI); Hybrid; USD 89,000 - 149,000; Full time

Job summary

Stryker is seeking a Senior Quality Engineer to support product and process quality across manufacturing operations for Instruments in Portage, Michigan. You will partner with operations, engineering, suppliers, and quality teams to drive compliance, resolve quality issues, support new product introductions and manufacturing scale up activities, and lead continuous improvement initiatives.

Key responsibilities include investigations, CAPA closure, data analysis, supplier collaboration, and

Qualifications

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• Minimum 2 years of quality engineering, manufacturing engineering, or related engineering experience.
• Experience supporting non-conformance investigations, corrective and preventive actions, or quality management systems.

Responsibilities

• Partner with manufacturing, engineering, and quality teams to monitor and improve product and process quality performance.
• Support the transfer, launch, and scale-up of new products and manufacturing processes, partnering cross-functionally to establish robust quality systems and ensure successful production readiness.
• Support or lead investigations and timely closure of non-conformances and corrective and preventive actions, including root cause analysis and implementation of corrective actions.
• Review and disposition nonconforming materials and products through Material Review Board processes.
• Collaborate with suppliers to address quality issues, manage supplier corrective actions, and support supplier quality improvement initiatives.
• Evaluate and support manufacturing, supplier, and engineering changes to ensure compliance with quality and regulatory requirements.
• Monitor quality performance indicators, analyze trends, and implement actions to address identified risks and improvement opportunities.
• Support continuous improvement initiatives focused on quality enhancement, scrap reduction, efficiency gains, and cost savings.
• Support process validation, equipment qualification, inspection methods, measurement system analysis, and statistical process controls.
• Participate in internal and external audits, complaint investigations, field actions, and continuous improvement projects across manufacturing operations.

Skills

Quality engineering

Non-conformance investigations

Root cause analysis

Quality management systems

Education

Bachelor's degree in Engineering/Science

Tools

GD&T

Calipers

Micrometers

CMM

Pin gauges

Job description

Stryker is seeking a Senior Quality Engineer to support product and process quality across manufacturing operations for Instruments in Portage, Michigan. In this role, you will partner with operations, engineering, suppliers, and quality teams to drive compliance, resolve quality issues, support new product introductions and manufacturing scale up activities, lead continuous improvement initiatives, and ensure products meet applicable regulatory and quality requirements.

What You Will Do

• Partner with manufacturing, engineering, and quality teams to monitor and improve product and process quality performance.

• Support the transfer, launch, and scale-up of new products and manufacturing processes, partnering cross-functionally to establish robust quality systems and ensure successful production readiness.

• Support or lead investigations and timely closure of non-conformances and corrective and preventive actions, including root cause analysis and implementation of corrective actions.
• Review and disposition nonconforming materials and products through Material Review Board processes.
• Collaborate with suppliers to address quality issues, manage supplier corrective actions, and support supplier quality improvement initiatives.
• Evaluate and support manufacturing, supplier, and engineering changes to ensure compliance with quality and regulatory requirements.
• Monitor quality performance indicators, analyze trends, and implement actions to address identified risks and improvement opportunities.

• Support continuous improvement initiatives focused on quality enhancement, scrap reduction, efficiency gains, and cost savings.

• Support process validation, equipment qualification, inspection methods, measurement system analysis, and statistical process controls.
• Participate in internal and external audits, complaint investigations, field actions, and continuous improvement projects across manufacturing operations.

What You Will Need

Required Qualifications

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• Minimum 2 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

• Experience in the medical device industry.

• Experience analyzing quality data and applying statistical methods to support manufacturing or process improvements.

• Six Sigma Green Belt or Six Sigma Black Belt certification.
• Experience with geometric dimensioning and tolerancing (GD&T).
• Experience using metrology equipment such as calipers, micrometers, pin gauges, or coordinate measuring machines (CMMs).

USN: $89,300 - $148,800 USD Annual

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