Associate Quality Engineer

About the Role

We are hiring an Engineer, Quality Assurance to support quality assurance, manufacturing quality, and continuous improvement activities at a regulated manufacturing facility in Portage, Michigan. The successful candidate will work with engineering, manufacturing, operations, and supplier teams to investigate quality issues, support corrective and preventive actions, maintain quality documentation, and improve product and process quality. This opportunity is suitable for recent graduates and early-career professionals with relevant engineering education and exposure to quality systems.

Key Responsibilities

• Support manufacturing quality assurance and quality control activities.
• Investigate non-conformances and assist with root cause analysis.
• Support CAPA activities, including corrective action implementation and documentation.
• Assist with non-conforming product disposition and containment activities.
• Coordinate with suppliers to resolve quality issues and support supplier corrective actions.
• Review quality procedures, controlled documentation, and change management records.
• Monitor quality KPIs, analyze trends, and identify improvement opportunities.
• Support internal and external quality audits.
• Assist with manufacturing process validation, equipment qualification, and measurement system analysis.
• Support engineering changes, supplier changes, and manufacturing transfers.
• Participate in risk management and continuous improvement initiatives.
• Apply quality tools and statistical methods to improve manufacturing processes.

Requirements & Tech Stack

• Bachelor's degree in Engineering or a relevant technical discipline.
• 0–2 years of relevant experience in Quality Assurance, Quality Engineering, Quality Control, Regulatory Affairs, or manufacturing quality.
• Familiarity with CAPA, root cause analysis, non-conformance management, and quality documentation.
• Basic understanding of GMP, GDP, or ISO 13485.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Strong written and verbal communication skills.
• Excellent analytical, organizational, and problem-solving abilities.
• Ability to manage multiple tasks and collaborate with cross-functional teams.
• Willingness to travel occasionally when required.

Preferred Qualifications

• Internship or co-op experience in medical devices, pharmaceuticals, biotechnology, or manufacturing.
• Exposure to quality audits, change control, supplier quality, MRB, SCAR, or validation activities.
• Familiarity with risk management, statistical process control, or Lean principles.