Quality Manager

Our client located in the Germantown/Menomonee Falls area is seeking an experienced and proactive Quality Manager to lead the Quality functions at their tooling facility. In this role you will play a key part in advancing FOT to FAT (First‑Off Tool to Final Acceptance Testing) capabilities, strengthening the client’s quality systems, and supporting their continued growth of their tooling and production operations.

As part of the 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.

• Maintain and improve the Quality Management System (QMS) in accordance with ISO 9001, internal client 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 team planning aligned with business needs.
• Foster a professional, accountable, and safety‑focused team culture.
• Other duties as assigned.

• Bachelor’s degree in Engineering, Manufacturing, Quality, or related field is preferred.
• Minimum of 8+ years of experience in Quality, or equivalent combination of education and experience.
• Demonstrated experience in problem solving.
• Demonstrated statistical analysis skills.
• Strong knowledge of ISO 9001 and familiarity with ISO 13485.
• Experience in working with teams to achieve results.

• Mid‑Senior level

• Full‑time

• Management and Quality Assurance
• Plastics Manufacturing