Senior Quality Manager - Medical Devices & QMS Champion

Actalent; Lawndale (CA); On-site; USD 130,000 - 150,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision benefits

Paid time off

Retirement plan

Job summary

Actalent is seeking a Quality Manager to lead and continuously enhance the QMS ensuring FDA and ISO compliance. You will oversee quality engineering, QA, and QC, drive CAPA, and partner with cross-functional teams to embed quality throughout the product lifecycle.

You will report to senior leadership, analyze quality metrics, and lead training programs. This permanent, onsite role is based in Lawndale, CA, with a competitive salary and benefits package.

Qualifications

• Bachelors degree required in Engineering, Life Sciences or related field.
• 5+ years quality management experience in medical devices.
• Strong knowledge of FDA QSR and ISO-based QMS requirements.
• Experience maintaining a QMS in a regulated environment.
• CAPA processes including initiation, investigation, and verification.

Responsibilities

• Lead and improve the QMS in compliance with FDA and ISO standards.
• Plan and host internal and external audits including FDA inspections.
• Oversee CAPA, nonconformances, and complaint handling for timely resolutions.
• Collaborate with R&D, Manufacturing, and Regulatory to embed quality.
• Track quality metrics and present to senior leadership.
• Lead training on quality standards and procedures.
• Manage document and change control processes.
• Oversee risk management and mitigation activities.
• Supervise QA/QC staff and provide coaching.
• Support root cause analysis and sustainable corrective actions.
• Participate in special projects supporting quality/compliance.

Skills

QMS management

CAPA mechanics

Audit readiness

Root cause analysis

Leadership

Regulatory knowledge (FDA QSR)

Data-driven decision making

Cross-functional collaboration

Documentation control

Quality engineering/QA

Education

Bachelor's degree in Engineering/Life Sciences

Master's degree preferred

Job description

Actalent is seeking a Quality Manager to lead and continuously enhance the QMS ensuring FDA and ISO compliance. You will oversee quality engineering, QA, and QC, drive CAPA, and partner with cross-functional teams to embed quality throughout the product lifecycle.

You will report to senior leadership, analyze quality metrics, and lead training programs. This permanent, onsite role is based in Lawndale, CA, with a competitive salary and benefits package.