Indirect Labor - Quality - Quality Engineer

Primary Responsibilities

• Sustains quality activities for assigned programs, including part validation, qualification, and ongoing compliance.
• Participates in the organization’s Stage-Gate approach to product realization.
• Executes validation activities, such as IQ, OQ, and PQ protocols and reports, as directed.
• Supports and carries out quality planning activities including Process Flow Diagrams, Process FMEAs, and Control Plans.
• Prepares work instructions and inspection instructions.
• Acts as the primary quality contact for assigned customers, supporting customer quality concerns, investigations, and corrective actions.
• Creates and manages CAPAs, SCARs, RMAs, and sustaining programs.
• Serves on the internal audit team and leads customer audits for assigned programs and products, including audit preparation, participation, documentation, and coordination of responses and corrective actions, while supporting ISO 13485 and regulatory audits as assigned.
• Drives continuous improvement by analyzing quality data, identifying trends, and partnering with cross-functional teams to improve product and process performance.
• Improves manufacturing by reducing defects, scrap, rework, and customer complaints using Lean/Six Sigma tools and production data.
• Leads cross-functional problem-solving events (8D, DMAIC, A3), performs root cause analysis, and implements effective, sustainable CAPA for chronic quality and production issues.
• Collaborates with Production, Engineering, and Processing to standardize improved methods, update control plans and work instructions, and ensure process adherence on the shop floor.
• Coaches and trains operators, technicians, and supervisors in basic quality tools, standard work, and problem-solving methods to strengthen a culture of continuous improvement.
• Drives NCR and MRB processes, conducting investigations, dispositions, risk assessments, corrective actions, and closure of nonconforming material issues.

Qualifications And Skill Requirements

• B.S. Degree in Engineering or equivalent work experience required.
• 4+ years’ experience in a regulated manufacturing environment.
• Experience executing IQ, OQ, and PQ validation activities.
• Working knowledge of ISO 13485 and applicable FDA quality system requirements.
• Experience supporting customer audits and quality discussions.
• Strong root cause analysis and corrective action experience.
• Able to manage multiple projects concurrently.
• Strong understanding of print reading, cGMP/cGDP, GD&T, and cosmetic specifications.
• Experience with Epicor or similar ERP systems preferred.
• Experience with change control, revision control, and documentation.
• Valid identification and the ability to legally work in the United States.