What are the responsibilities and job description for the Quality Assurance Engineer position at GForce Life Sciences?
Quality Assurance Engineer
12-Month Contract
Onsite in Portage, MI
Summary
GForce Life Sciences has engaged a client to provide a Quality Assurance Engineer. This role will support quality assurance, quality control, and preventive activities to help ensure compliance with applicable regulations and standards.
DUTIES / EXPECTATIONS OF ROLE
12-Month Contract
Onsite in Portage, MI
Summary
GForce Life Sciences has engaged a client to provide a Quality Assurance Engineer. This role will support quality assurance, quality control, and preventive activities to help ensure compliance with applicable regulations and standards.
DUTIES / EXPECTATIONS OF ROLE
- Partner with Operations and business functions to support product and process quality performance.
- Collaborate cross-functionally (internal/external) to investigate and resolve quality issues.
- Own/manage internal and supplier nonconformances (NCs), including investigation and timely closure.
- Support/own CAPAs from root cause analysis through closure.
- Support disposition of nonconforming product through MRB; issue NCs as appropriate.
- Communicate with suppliers on NCs; escalate SCARs as needed.
- Support change management activities (internal and supplier) and continuous improvement of manufacturing processes.
- Create and/or review new or revised procedures.
- Maintain/analyze KPIs to monitor quality; identify trends and implement corrective actions.
- Support manufacturing complaints and product field action execution/analysis.
- Apply statistical methods for process analysis and control.
- Provide QA support during internal and external audits.
- Support process/equipment validation, qualification, and MSA activities.
- Execute quality deliverables for engineering changes, manufacturing transfers, and supplier changes.
- Support product holds and containment plans; assist with quality acceptance tests (QATs).
- Support risk management practices/tools and Lean principles (standardization, waste elimination).
- Manage supplier relationships related to performance, communications, and nonconformities.
- 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 quality/engineering principles, including Risk Management, CAPA, Audits, and Statistics.
- Proficiency with Microsoft Word, Excel, and PowerPoint.
- Excellent written and spoken English.
- Willingness to work as part of a multi-site team; some travel required.
- Prior industry experience (desirable).
- Knowledge of risk-based thinking and statistical concepts (a plus).