Quality Engineer

iMPact Business Group; Portage (MI); On-site; USD 85,000 - 105,000; Full time

Job summary

Impact Business Group is assisting a Global Leader in the Medical Device sector by filling a Quality Engineer contract role in Portage, Michigan for 12 months, with the possibility of extension.

The successful candidate will partner with Operations and manufacturing teams to improve product quality, lead CAPAs, manage NCs, and support supplier quality, audits, and process validation. Strong analytical and communication skills are essential.

Qualifications

• Experience in quality engineering within medical device manufacturing.
• Familiar with CAPA, NCs, MRB and QAT processes.
• Strong analytical and problem-solving skills.

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 escalates 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.

Skills

Quality engineering

Root cause analysis

CAPA

Statistical methods

QA audits

Job description

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Quality Engineerfor 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.

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 escalates 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.