Job Title: Quality Assurance Engineer Location: Portage, MI Type: Contract Compensation: $47-$52/hr Work Model: Onsite
Overview
The Engineer, Quality Assurance will play a proactive role in supporting quality assurance, quality control and preventive activities to ensure compliance with regulations and standards. Collaborate with cross-functional teams, assist in resolving quality issues, and contribute to continuous improvement initiatives within manufacturing and quality processes.
Responsibilities
- Work closely with Operations and Business Functions to ensure quality performance of products and processes
- Collaborate cross-functionally with internal and external teams to resolve quality issues
- Own and manage internal and supplier-driven Non-Conformances (NCs), ensuring timely investigation and closure
- Support or own Corrective and Preventive Actions (CAPAs) through root cause analysis to closure
- Disposition of non-conforming product through MRB, issuing NCs as appropriate
- Communicate with suppliers regarding NCs and escalate Supplier Corrective Action Requests (SCARs) as needed
- Participate in the development and continuous improvement of internal manufacturing processes for existing products
- Review and support Change Management activities (both supplier and internal)
- Create and/or review new or revised procedures
- Maintain and analyze KPIs 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 QA support during internal and external audits
- Support process/equipment validation, qualification, and Measurement System Analysis (MSA)
- Execute internal quality deliverables for engineering changes, manufacturing transfers, and supplier changes
- Assist in manufacturing/product transfers between plants/facilities, performing appropriate quality activities
- Execute and analyze Quality Acceptance Tests (QATs)
- Support with product holds and executing containment Plans
- Support in risk management practices and tools, use knowledge in process risk. Support and provide input for risk management by identifying opportunities and weaknesses.
- Support and implement Lean principles through standardization and waste elimination
- Understanding of Human Error Prevention and the application of those principles to the manufacturing environment.
- Manage supplier relationships, including but not limited to, coordinating communications, monitoring performance, managing in house and external nonconformities and ensuring timely delivery of quality materials and services.
Requirements
- Bachelor’s Degree
- 0–2 years’ experience in a Quality or Regulatory Affairs role
- Familiar with ISO 13485, GDP, and GMP concepts
- Solid understanding of engineering and quality principles, including Risk Management, CAPA, Audits, and Statistics
- Proficient in Microsoft Word, Excel, and PowerPoint
- Strong problem-solving, analytical, and communication skills with high attention to detail
- Builds strong relationships through open communication, respect, and trust
- Team player with a customer/stakeholder-focused approach
- Diplomatic, tactful, and effective at leveraging interpersonal skills
- Embraces change with a continuous improvement mindset.
- Excellent written and spoken English
- Confident representing Quality in cross-functional settings
- Self-starter able to manage multiple tasks in a fast-paced environment
- Willing to work as part of a multi-site team; some travel required
Preferred
- Prior industry experiences desirable
- Knowledge of risk-based thinking and statistical concepts is a plus
System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
#LI- Ref: #558-Scientific