Quality Engineer II
On-siteSalem, New Hampshire, United States
Job Summary
Assure manufacturing operations follow Good Manufacturing Practices and FDA/ISO 13485 standards. Participate in multidisciplinary teams for root-cause analysis, corrective and preventive actions, and process improvement events to reduce cost of poor quality. Design, execute, and document gage R&R studies while leading SCAR processes for supplier notifications and effectiveness reviews. Investigate customer complaints, manage process validations, and implement SPC to eliminate customer escapes. Create control plans, execute engineering studies, and support the Lean QMS initiative to reduce waste. Collaborate in specification clarifications, internal audits, and quality department meetings to meet KPI goals and support supplier management.
Required Qualifications
- Assure that manufacturing operations follow all Good Manufacturing Practices and Procedures as defined by insuring that FDA and Quality Standards are met
- Participate in multidisciplinary teams to implement root-cause analysis, corrective and preventive action, and proof of effectiveness as quality issues are identified
- Design, execute and document gage R&R studies
- Support training on Manufacturing and Quality System documents (SOPs, PIs, MAPs, QAPs)
- Actively lead process improvement events leading to reduction in cost of poor quality (COPQ)
- Reduce scrap and manufacturing waste for various product lines throughout the factory
- Quality Representative for Material Review Board (NMR) for purchased and make components
- Conduct and follow up of SCAR process (SCAR issuance, Supplier notification, SCAR approval and effectiveness review)
- Investigate and respond to customer complaints and customer issued SCARs
- Quality Representative for Process Validations and Transfer Validations (may require writing, reviewing, executing, analyzing and reporting on test protocols)
- Prepare quality related deliverables in a timely manner
- Prepare and execute Engineering studies as needed
- Responsible for CAPA root cause investigation and actions implementation
- Implementation of SPC
- Eliminate All Escapes to the customer
- Creates Controls plans
- Meet KPI Goals,Quality deliverables
- Support Quality Culture
- Lean QMS initiative to reduce Muda by eliminating bureaucratic processes
- Participate and assist as a part of the Internal Audit team as required
- Follow medical device manufacturing best practices (GMP, GDP, etc.), current Nordson Medical policies and procedures, ISO 13485, 21CFR Part 820 and other applicable regulations to ensure compliance to applicable customer and regulatory requirements
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