Onsite Staff Quality Engineer – Medical Devices, Scale-Up

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

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.