Responsibilities will include -
• Monitor and report on key quality metrics, trends, and risks to senior management.
• Champion Nadcap special process compliance in Metallurgy, NDT, and Chemical Processing.
• Coach and mentor junior quality and inspection team members, fostering a culture of quality awareness and accountability.
• Lead and support internal and external quality audits (customer, regulatory, and Nadcap) across the forge and machining areas, ensuring audit readiness and compliance.
• Investigate and resolve complex quality issues, including root cause analysis (RCA), corrective and preventive action (CAPA), and the use of quality tools such as 8D, PFMEA, and control plans
• Drive continuous improvement initiatives and support the development and maintenance of quality management systems aligned withAS9100, ISO13485, AS13100, Nadcap and 21 CFR 820.
• Collaborate with engineering, manufacturing, and inspection teams to improve product quality and ensure effective process controls are in place
• Provide technical support in metallurgical and materials-related quality concerns, particularly in forging, heat treatment, and machining operations.
• Review and approve quality documentation, including FAIRs, inspection reports, PPAPs, and manufacturing process plans.
• Interface with customers and regulatory bodies on quality matters, non-conformance resolution, and continuous improvement updates.
Experience required:
• Significant experience in a senior quality engineering role within a regulated manufacturing environment (e.g. aerospace, medical devices, or precision engineering).
• Proven success managing internal and external audits and resolving complex quality issues under pressure.
• Experience in root cause analysis, CAPA, and the application of quality tools such as 8D, FMEA, SPC, and MSA.
• Experience with eQMS software systems (e.g., ETQ Reliance, SAP, Plex, or similar) preferable.
Knowledge, Skills, and Abilities:
• Resilient and adaptable, capable of performing in a high-demand, fast-paced environment.
• Strong leadership, communication, and problem-solving skills, with the ability to manage cross-functional teams and influence change.
• Strong working knowledge of AS9100, ISO13485, AS13100, Nadcap, and 21 CFR 820 requirements.
• Solid understanding of forging processes, machining, special processes (NDT, heat treatment, chemical processing), and metallurgical principles.
• Ability to interpret engineering drawings, technical specifications, and customer requirements.
Qualifications Required:
• Preferably a degree in Metallurgy, Materials Science, Mechanical Engineering, or related field.
• Preferably certified Lead Auditor or equivalent in AS9100 or ISO13485