Quality Assurance Engineer

Wilson • Portage, MI

1d • Onsite

About The Position

The Quality Assurance Engineer proactively supports quality assurance, quality control, and preventive activities to ensure compliance with regulations and standards. The role collaborates with cross-functional teams to resolve quality issues and contributes to continuous improvement across manufacturing and quality processes. It supports manufacturing and product quality, supplier quality, audits, risk management, validation, and product or process changes. The position is based in Portage, Michigan, with a stated 12-month duration and compensation of $52 per hour. The schedule is 8:00 a.m.–5:00 p.m. CST, with flexibility in start and end times depending on support needs.

Requirements

• Bachelor’s degree.
• 0–2 years of experience in a Quality or Regulatory Affairs role.
• Familiarity with ISO 13485, GDP, and GMP concepts.
• Solid understanding of engineering and quality principles, including risk management, CAPA, audits, and statistics.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Strong problem-solving, analytical, and communication skills, with high attention to detail.
• Ability to build strong relationships through open communication, respect, and trust.
• Team-oriented approach with a focus on customers and stakeholders.
• Diplomatic and tactful, with effective interpersonal skills.
• Continuous improvement mindset and willingness to embrace change.
• Excellent written and spoken English.
• Confidence representing Quality in cross-functional settings.
• Self-starter able to manage multiple tasks in a fast-paced environment.
• Willingness to work as part of a multi-site team; some travel is required.

Nice To Haves

• Prior industry experience is desirable.
• Knowledge of risk-based thinking and statistical concepts.

Responsibilities

• Work with Operations and business functions to ensure quality performance of products and processes.
• Collaborate with internal and external teams to resolve quality issues.
• Own and manage internal and supplier-driven non-conformances, ensuring timely investigation and closure.
• Support or own Corrective and Preventive Actions (CAPAs), from root cause analysis through closure.
• Disposition non-conforming product through the Material Review Board (MRB) and issue non-conformances as appropriate.
• Communicate with suppliers about non-conformances and escalate Supplier Corrective Action Requests (SCARs) as needed.
• Participate in developing and continuously improving manufacturing processes for existing products.
• Review and support supplier and internal change management activities.
• Create or review new and revised procedures.
• Maintain and analyze key performance indicators to monitor product and process quality, identify trends, and implement corrective actions.
• Support the execution and analysis of manufacturing complaints and product field actions.
• Apply statistical methods for process analysis and control.
• Provide Quality Assurance support during internal and external audits.
• Support process and equipment validation, qualification, and Measurement System Analysis (MSA).
• Execute internal quality deliverables for engineering changes, manufacturing transfers, and supplier changes.
• Assist with manufacturing and product transfers between plants or facilities by performing appropriate quality activities.
• Execute and analyze Quality Acceptance Tests (QATs).
• Support product holds and execute containment plans.
• Support risk management practices and tools, identifying opportunities and weaknesses and providing input to risk management.
• Support and implement Lean principles through standardization and waste elimination.
• Apply Human Error Prevention principles in the manufacturing environment.
• Manage supplier relationships, including communications, performance monitoring, non-conformity management, and timely delivery of quality materials and services.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level