Quality Assurance Manager

RenyMed; Baldwin Park (CA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Disability insurance

Job summary

A precision tooling company in Baldwin Park is looking for a Quality Manager to oversee the quality management system, ensuring compliance with regulations and driving continuous improvement. This role involves leading audits, collaborating with cross-functional teams, and implementing Lean Six Sigma methodologies. Candidates should have at least 10 years of experience in quality assurance within the medical device sector, a relevant bachelor's degree, and preferably hold certifications in quality engineering.

Qualifications

• Minimum 10 years of experience in quality assurance or quality engineering in medical device manufacturing.
• Proven track record of leading quality teams and ensuring regulatory compliance.
• Certifications such as CQE, Six Sigma, or ISO 13485 Lead Auditor preferred.

Responsibilities

• Oversee and enhance the company’s quality management system.
• Ensure compliance with medical device manufacturing regulations.
• Lead quality audits and ensure timely corrective actions.
• Implement Lean Six Sigma methodologies for continuous improvement.

Skills

Quality Management & Compliance

Process Improvement & Lean Methodologies

Leadership & Team Development

Analytical & Problem‑Solving Skills

Education

Bachelor’s degree in Engineering or Quality

Tools

ISO 13485

FDA regulations

GMP requirements

Lean Six Sigma

Job description

Be among the first 25 applicants for this role.

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

About the Company

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.

About the Role

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

Responsibilities

Quality Leadership & Compliance

• 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.

Quality Control & Assurance

• 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.

Continuous Improvement & Lean Quality Initiatives

• 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.

Supplier & Customer Quality Management

• 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.

Safety & Regulatory Compliance

• 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.

Cross‑Functional Collaboration

• 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 design through production, facilitating manufacturability and efficient production ramp‑up.
• Collaborate with Production and Engineering teams to address quality‑related challenges, implement corrective actions, and drive continuous improvement.
• Partner with Vice President, Human Resources and Quality Supervisor to develop quality‑related training programs for employees, reinforcing best practices in regulatory compliance and process controls.
• Lead cross‑functional meetings to align teams, improve communication, and drive company‑wide success by fostering a culture of quality excellence and operational efficiency.

Other Duties

• Perform additional tasks as assigned by the President/CEO to support quality and business objectives.

Qualifications

• Education: Bachelor’s degree in Engineering, Quality, or a related field required. Advanced degree preferred.
• Industry Experience: Minimum 10 years of experience in quality assurance or quality engineering in medical device manufacturing or plastic injection molding. Proven track record of leading quality teams, driving process improvements, and ensuring regulatory compliance.
• Certifications: CQE, Six Sigma, or ISO 13485 Lead Auditor Certification preferred.

Required Skills

• Quality Management & Compliance: Extensive experience in ISO 13485, FDA, GMP, and ISO 14971 risk management requirements. Strong background in quality audits, CAPA investigations, and validation processes.
• Process Improvement & Lean Methodologies: Strong understanding of Lean Six Sigma principles and process optimization techniques. Experience implementing continuous improvement initiatives to enhance efficiency and reduce defects.
• Leadership & Team Development: Ability to lead and mentor a diverse team across multiple quality functions. Strong interpersonal and communication skills to engage with employees, leadership, customers, and regulatory agencies.
• Analytical & Problem‑Solving Skills: Strong problem‑solving abilities using root cause analysis, risk assessments, and statistical methods. Ability to analyze quality metrics, identify trends, and implement effective corrective actions.

Additional Information

Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Quality Assurance and Management

Benefits may include medical insurance, vision insurance, 401(k), and disability insurance.