Staff Quality Engineer

RiseMe; Portage (MI); On-site; USD 89,000 - 149,000; Full time

Job summary

Stryker is seeking a Staff 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, lead continuous improvement initiatives, and ensure products meet regulatory requirements.

Qualifications

• Bachelor's degree in Engineering, Science, or related technical discipline.
• Minimum 4 years of quality, manufacturing, or related engineering experience.
• Experience with non-conformance investigations, CAPA, or QMS.

Responsibilities

• Partner with manufacturing, engineering, and quality teams to monitor and improve product and process quality performance.
• Support transfer, launch, and scale-up of new products and processes, ensuring production readiness.
• Lead investigations and closure of non-conformances and CAPA with root-cause analysis and corrective actions.
• Review and disposition nonconforming materials via MRB processes.
• Collaborate with suppliers to address quality issues and support supplier quality improvements.
• Evaluate changes to ensure quality and regulatory compliance.
• Monitor quality metrics, analyze trends, and address risks and opportunities.
• Lead CI initiatives focused on quality, scrap reduction, and efficiency gains.
• Support process validation, equipment qualification, inspection methods, MSA, and SPC.
• Participate in audits, complaints, field actions, and continuous improvement projects.

Skills

Quality Engineering

Manufacturing Engineering

Statistical Analysis

Root Cause Analysis

Six Sigma

Education

Bachelor's degree in Engineering/Science

Tools

GD&T

CMMs

Job description

Work Flexibility: Onsite

Stryker is seeking a Staff 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.

• 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.

• Lead or 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 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

• 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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Travel Percentage: 20%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.