Quality Engineer

Position Summary

The Quality Engineer is responsible for leading continuous improvement of products and processes, ensuring the successful introduction of new and changing products, and working cross‑functionally with Operations, Engineering, Supply Chain, Sales/Commercial, Customer Care, Specification Review & Development, and external customers. The Quality Engineer develops and maintains risk analyses (e.g., FMEAs), coordinates PPAP/First Article submissions, designs Certificates of Conformance/Analysis (CoC/CoA), performs root‑cause analysis, implements corrective and preventive actions to improve capability and control ongoing performance, and supports the planning, hosting, and execution of internal and external audits.

• Create, maintain, and use design and process risk analyses (e.g., FMEAs); drive risk mitigation with Operations, Engineering, Supply Chain, Sales/Commercial, and Customer Care.
• Own and drive Quality Management System processes, including CAPA, nonconforming material investigations, and complaint support; ensure timely, compliant execution and robust effectiveness verification.
• Develop inspection requirements for production and quality control; design and generate CoC/CoA templates and outputs as required by customers.
• Plan, compile, and submit PPAP and First Article packages; coordinate measurement data, capability studies, and required documentation with internal teams and suppliers.
• Identify and report quality trends; implement controls and standard quality procedures to detect, contain, and prevent nonconformances.
• Lead structured, data-driven investigations into complex quality issues, ensuring root cause is supported by objective evidence, risk-based thinking, and comprehensive documentation suitable for customer and regulatory review.
• Initiate and/or support capital requests and strategic activities to improve product and process quality and process capability.
• Coordinate and lead cross‑functional responses to customer concerns; manage timely, professional communication and conflict resolution with customers.
• Teach and coach best practices in SPC, MSA/GRR, DOE basics, statistical quality control, and standard work documentation.
• Plan, prepare, host, and participate in internal and external audits, which may include leading backroom activities, reviewing documentation for compliance, supporting auditor interactions, and ensuring timely closure of findings.
• Support and/or lead validation activities (IQ/OQ/PQ) and change management processes, including risk assessments, protocol review, and implementation of quality requirements (e.g., ISO 13485 and, where applicable, ISO 9001/9000).
• Ensure accuracy and integrity of quality data within ERP systems (e.g., SAP), including traceability of materials, batch records, and inspection data; support investigations involving data discrepancies and systemic improvements.

Education

• Bachelor’s degree in Engineering, Statistics, or a related Science field; or equivalent combination of education and relevant experience.

Experience

• 0–5 years in a quality role within manufacturing; shop‑floor experience troubleshooting daily quality issues.
• Strong analytical skills, including the use of simple and complex quality tools.
• Working knowledge to perform and lead kaizen/continuous improvement events.
• Solid verbal and written communication; strong technical writing and documentation skills.

Preferred Qualifications

• Proficiency with MS Office and ERP systems; exposure to statistical software (e.g., Minitab) and basic CRM (e.g., Microsoft Dynamics) usage.
• Demonstrated analytical skills and use of quality tools (SPC, MSA/GRR, DOE, capability analysis).
• Working knowledge of ISO 13485; familiarity with FDA Good Manufacturing Practices (GMP).
• ASQ Certified Quality Engineer.
• Certified Six Sigma Green Belt.

Senior Quality Engineer

• 6+ years of progressive quality engineering experience; demonstrated leadership of cross‑functional improvement and new product introduction activities.
• Experience developing and implementing quality systems and processes within existing business units.
• Proficiency with advanced statistical methods and tools (e.g., DOE, capability studies) and audit leadership.
• Customer‑facing experience, including complex complaint management, PPAP ownership, and external communication.
• Preferred: visual inspection system development, PLC automation/controls knowledge, and mentoring/coaching of engineers and technicians.

• Prolonged periods working at a computer; regular presence in manufacturing areas.
• Must be able to lift to 50 lbs.
• Various levels of gowning may be required in controlled areas.

• Ability to travel domestically and internationally, as needed.
• Ability to work evenings and/or weekends based on business needs.