Quality Manager - Manufacturing

We are seeking an experienced and proactive Quality Manager to lead the Quality function at our US Tooling Facility. This individual will play a key role in advancing FOT to FAT (First-Off Tool to Final Acceptance Testing) capabilities, strengthening our quality systems, and supporting the continued growth of our tooling and production operations. As part of the US Tooling Management Team, the Quality Manager will be responsible for maintaining and improving quality processes that align with ISO standards, customer expectations, and regulatory requirements. The role includes supporting the Metrology Lab and Incoming Inspection, as well as managing and developing the team responsible for these activities. Additionally, this position will oversee the coordination of both internal and external inspection resources to ensure quality requirements and timelines are met. Below are additional duties and responsibilities : Maintain and improve the Quality Management System (QMS) in accordance with ISO 9001, internal MGS procedures, customer-specific requirements, and applicable regulatory standards. Support compliance efforts related to ISO 13485 and 21 CFR Part 820 for medical device manufacturing, ensuring alignment with regulatory expectations for documentation, process control, and traceability. Ensure readiness for and assist in internal, second-party, and third-party audits, including effective response and implementation of corrective actions for audit findings. Conduct Layered Process Audits and support ongoing quality assurance activities within cleanroom and non-cleanroom environments. Maintain understanding of cleanroom protocols, gowning practices, and cleanliness requirements to support manufacturing in controlled environments. Ensure proper interpretation and application of medical customer-specific requirements, supporting consistent delivery of compliant and high-quality products. Provide mentorship, support, and direction for the Quality and Metrology team. Conduct performance evaluations, identify development opportunities, and address skill gaps. Collaborate with HR on staffing, training, and team planning aligned with business needs. Foster a professional, accountable, and safety-focused team culture. Any other duties as assigned.