Onsite QMS Lead – Quality & Compliance Manager

Akkodis; Corona (CA); On-site; USD 120,000 - 138,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Commuter benefits

401K plan

Paid leave

Job summary

Akkodis seeks a Quality Management System Supervisor to lead QMS activities, drive audits, and ensure regulatory compliance at our Corona, CA site. The role is full-time and onsite, with responsibilities spanning training, KPI development, and cross-functional collaboration to sustain operational excellence.

Ideal candidates bring 5+ years of QMS leadership in regulated manufacturing, strong ISO 13485 and FDA Part 820 knowledge, and a proven track record in continuous improvement and cross-team

Qualifications

• Bachelor's degree from an accredited college or university.
• 5+ years leading and managing a QMS in a regulated manufacturing environment.
• Medical device industry experience preferred.
• 5+ years of cross-functional leadership.
• 5+ years of direct people management experience.
• Experience leading internal and external audit programs.
• Liaison with regulatory agencies and certification bodies on quality matters.
• Strong knowledge of ISO 13485 and FDA 21 CFR Part 820 requirements.
• Excellent communication, problem-solving, and organizational skills.
• Proven ability to drive continuous improvement with measurable results.

Responsibilities

• Oversee site QMS activities to ensure timely and effective execution.
• Establish, maintain, and improve the site's QMS per industry standards and regs.
• Lead internal audit program and address findings effectively.
• Coordinate and lead customer audits conducted at the site.
• Manage external certification and regulatory contacts.
• Ensure QMS training programs are current and effective across the org.
• Conduct process-based internal audits per the audit schedule.
• Develop, implement, and monitor KPIs to measure QMS performance.
• Review inputs for Management Review Meetings with complete reporting.
• Partner with site leadership to identify continuous improvement opportunities.
• Oversee and maintain the quality training program.
• Ensure compliance with health, safety, environmental and quality policies.

Education

Bachelor's degree from an accredited college or university

Tools

ISO 13485 knowledge

FDA 21 CFR Part 820 knowledge

Job description

Akkodis seeks a Quality Management System Supervisor to lead QMS activities, drive audits, and ensure regulatory compliance at our Corona, CA site. The role is full-time and onsite, with responsibilities spanning training, KPI development, and cross-functional collaboration to sustain operational excellence.

Ideal candidates bring 5+ years of QMS leadership in regulated manufacturing, strong ISO 13485 and FDA Part 820 knowledge, and a proven track record in continuous improvement and cross-team