What are the responsibilities and job description for the Quality Assurance Engineer position at WilsonCTS?
Work Location: Michigan, USA
Position Type: 12 months
Location: 3800 East Centre Ave, Portage, MI 49002
Compensation Range: $52 per hour
Shift: 8-5:00 EST (candidate should have flexibility in start/end time as these will vary based on what they are supporting)
Our client, medical technology (MedTech) company located in Portage, MI looking to hire Engineering roles.
Position Summary:
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.
Essential Duties & Responsibilities: (Detailed Description)
- 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.
Education & Special Trainings:
- Bachelor's Degree
Qualifications & Experience:
- 0-2 years' experience in a Quality or Regulatory Affairs role; prior industry experiences desirable
- 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
- Knowledge of risk-based thinking and statistical concepts is a plus
Salary : $52