Quality Assurance Manager

Be among the first 25 applicants for this role.

The range provided by Reny Med is $110,000 – $150,000 per year. Your actual pay will be based on your skills and experience.

Reny Med is a leader in precision tooling and advanced manufacturing solutions, specializing in high‑quality custom molds for a wide range of industries, with a strong focus on the medical device sector. Our mission is to produce tooling solutions that are technically advanced and make a positive impact on society, guided by our values of Care, Quality, and Creativity.

The Quality Manager will oversee and enhance all aspects of the company’s quality management system to ensure compliance, efficiency, and continuous improvement.

• Develop, implement, and maintain a robust Quality Management System (QMS) in compliance with ISO 13485, FDA, GMP, and customer‑specific requirements.
• Ensure compliance with all medical device manufacturing regulations, including documentation, validation, and risk management protocols.
• Lead quality audits (internal, supplier, customer, and regulatory) and ensure timely corrective actions for audit findings.
• Serve as the company’s primary point of contact for regulatory agencies and customer quality representatives.

• Oversee in‑process and final inspections to ensure product quality meets or exceeds customer expectations.
• Implement and maintain statistical process control (SPC), process capability studies, and other quality control methodologies to enhance operational performance.
• Drive root cause analysis, corrective actions (CAPAs), and continuous improvement initiatives to reduce non‑conformances and enhance product quality.
• Collaborate with engineering and production teams to ensure quality is built into the design and manufacturing processes.
• Oversee validation activities (IQ, OQ, PQ) for processes, equipment, and products to ensure regulatory compliance.
• Lead risk management initiatives in accordance with ISO 14971, ensuring robust failure mode and effects analysis (FMEA) for all processes.
• Ensure proper documentation and traceability for validation and risk management activities.

• Implement Lean Six Sigma methodologies to drive continuous improvement and enhance operational efficiency.
• Develop and execute quality improvement projects, focusing on defect reduction, process optimization, and cost savings.
• Work cross‑functionally with manufacturing, engineering, and supply chain teams to optimize workflows and eliminate waste.

• Develop and maintain supplier quality programs, including audits, corrective actions, and performance monitoring.
• Manage customer complaints, deviations, and non‑conformances, ensuring timely resolution and root cause analysis.
• Build and maintain strong relationships with customers, suppliers, and regulatory agencies to support business objectives.
• Supervise and mentor the Quality Supervisor, Quality Inspectors, 1st Article Inspectors, Validation Engineer, Quality Engineer, Document Control Specialist, and Shipping Manager.
• Provide training and development programs to enhance team skills, technical knowledge, and regulatory compliance understanding.
• Foster a culture of accountability, teamwork, and continuous learning across the quality department.
• Partner with the Vice President of Human Resources to implement leadership development programs and organizational structure enhancements.

• Ensure compliance with OSHA regulations and company safety policies within the quality department.
• Promote safe work practices in all quality‑related operations, including inspections and validations.
• Identify potential risks and implement preventative measures to ensure workplace safety.

• Work closely with Engineering, Production, Tooling, Sales, HR, Facilities, and Customer Service to ensure company objectives are met while maintaining quality and regulatory compliance.
• Support new product development initiatives, ensuring that quality standards are integrated from…