Quality Manager

General Purpose

This key leadership position is responsible for leading all aspects of Quality processes and systems, managing the Quality Management System (QMS), internal and external audits, regulatory and safety compliance, and leading a team of Quality Technicians. The role collaborates with cross-functional teams to drive continuous improvement, ensure product integrity, and exceed customer expectations.

• Serve as the primary point of contact for quality-related communications with customers and suppliers.
• Manage customer complaints, lead investigations, and coordinate timely, effective resolution.

• Maintain the Quality Management System (QMS) in compliance with ISO 13485 and applicable customer/regulatory requirements.
• Own Document Control for QMS and production documents (Work Orders, labels, Certificates of Conformance, inspection forms), ensuring revision control, approvals, controlled release, and record retention.
• Lead internal and external audits (customer, supplier, registrar), including audit preparation, execution, follow-up, and reporting to the Executive Team.
• Own the metrology and test equipment program (calipers, gauges, vision systems, clean room monitoring equipment, etc.), including calibration/verification, status control, and records management.
• Oversee equipment qualifications and process validations to ensure ongoing compliance and product integrity.

• Drive robust Root Cause Analysis and CAPA execution for internal and external nonconformances.
• Lead and develop the Quality team, including supervision of Quality Technicians and daily quality execution on the production floor.
• Manage supplier quality performance, including supplier evaluations, audits, incoming quality issues, and nonconformance resolution.
• Maintain clean room quality standards, environmental controls, and monitoring/testing protocols.
• Assess quality organizational needs and build a high-performing team aligned with business growth and customer requirements.

• Lead and oversee the company’s Continuous Improvement (CI) program to drive process optimization, quality performance, and operational excellence.
• Partner cross-functionally to identify improvement opportunities, implement solutions, and sustain gains.
• Partner with company leadership to define quality strategy, establish KPIs, and drive continuous improvement.
• Evaluate and implement best practices, tools, technologies, and systems that strengthen quality, compliance, and manufacturing capability.
• Develop, maintain, and enforce manufacturing SOPs, work instructions, and standard work to ensure consistent execution and training alignment.
• Identify and mitigate operational risks affecting product quality, safety, delivery performance, and regulatory/customer compliance.
• Manage organizational safety programs, including compliance with the IIPP (Injury and Illness Prevention Program) and related safety requirements.

• Lead and oversee company-wide training and employee development programs, including the implementation, development, and leadership of quality- and safety-related training, to support performance, compliance, and organizational capability, and ensure employees are competent to perform assigned duties and meet QMS requirements.
• Administer the Learning Management System (LMS), maintaining current training content, training matrices, and complete/accurate training records to support audits and continuous improvement.

• Bachelor’s degree in a quality, manufacturing, engineering, or medical device related field.
• 4+ years in a Quality leadership role within a manufacturing environment.
• 3+ years managing a QMS within ISO 13485 or other ISO Standards within a manufacturing environment, and leading customer/supplier audits.
• Proven experience with precision component manufacturing and contract manufacturing environments.
• Hands‑on experience with CAPA, root cause investigations, and quality metrics.
• Familiarity with medical device manufacturing and regulated industries (Preferred).
• Familiarity with…