QMS Supervisor

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

As a Quality Management System Supervisor, you will lead and oversee Quality Management System (QMS) activities, including internal audits, management reviews, regulatory compliance, and continuous improvement initiatives. Working closely with cross-functional teams, you will ensure that quality systems remain effective, compliant, and aligned with industry standards while supporting operational excellence.

Full-time role

Salary: 120,000 - 137, 500 + 6% bonus

Onsite 5 days a week in Corona, CA

Key Responsibilities

• Oversee all site QMS activities to ensure timely and effective execution.
• Establish, maintain, and continuously improve the site's Quality Management System in accordance with applicable industry standards and regulations, including FDA 21 CFR-Part 820, ISO 13485, ISO 14001, ISO 9001, and ISO 45001.
• Lead and manage the internal audit program, ensuring that audit findings and nonconformities are effectively addressed, corrected, and independently verified.
• Coordinate and lead customer audits conducted at the site.
• Manage external certification and registration activities, serving as the primary point of contact for regulatory and certification bodies.
• Ensure QMS training programs are effective, current, and consistently implemented across the organization.
• Conduct process-based internal audits according to the established audit schedule and evaluate the effectiveness of quality processes.
• Develop, implement, and monitor key performance indicators (KPIs) to measure and improve QMS performance.
• Review and assess all required inputs for Management Review Meetings (MRMs), ensuring complete and accurate reporting.
• Partner with site leadership and management teams to identify opportunities for continuous improvement and implement enhancements to quality processes and systems.
• Oversee and maintain the quality training program.
• Ensure compliance with all applicable health, safety, environmental, and quality policies, procedures, and regulations.

Required Qualifications

• Bachelor's degree from an accredited college or university.
• Minimum of 5 years of experience leading and managing a Quality Management System within a regulated manufacturing environment; medical device industry experience preferred.
• Minimum of 5 years of demonstrated leadership experience managing cross-functional teams and driving organizational initiatives.
• Minimum of 5 years of direct people management experience.
• Proven experience leading internal and external audit programs.
• Experience serving as a liaison between internal stakeholders, customers, regulatory agencies, and certification bodies on quality-related matters.
• Strong knowledge of ISO 13485 and FDA 21 CFR Part 820 requirements.
• Excellent communication, problem-solving, and organizational skills.
• Demonstrated ability to drive continuous improvement initiatives and achieve measurable results.

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client