Senior Quality Assurance Leader — Med Device & ISO 13485

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

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.