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.

Primary Responsibilities / Essential Functions

• 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.
• Cook up 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/GR&R, 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.

Basic Qualifications

• 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.
• 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/GR&R, 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.

Special Requirements

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