Quality Engineer

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Quality Engineer for a 12 month + Contract.  Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.  

The Quality Assurance Engineer 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.