Indirect Labor - Quality - Quality Engineer

Quality Assurance Specialist

Primary Responsibilities:

• Supports development and sustaining quality activities for assigned programs, including part validation, qualification, and ongoing compliance.
• Participates in the organization's Stage-Gate approach to product realization.
• Supports and executes validation activities, including IQ, OQ, and PQ protocols and reports, as directed.
• 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.
• Participates in the creation and management of CAPAs, SCARs, RMAs, and sustaining programs.
• Supports disposition of internally produced nonconforming material.
• Works collaboratively with Manufacturing, Engineering, and Supply Chain to provide consultation and guidance on quality issues.
• 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.
• Continues improvement in manufacturing by using Lean/Six Sigma tools and production data to reduce defects, scrap, rework, and customer complaints.
• Leads cross-functional problem-solving events (8D, DMAIC, A3), performs root cause analysis, and implements effective, sustainable CAPA for chronic quality and production issues.
• Partners 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.
• Serves as the primary owner of NCR and MRB processes, driving investigation, disposition, risk assessment, 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.
• Ability 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.