What are the responsibilities and job description for the Quality Assurance Manager position at GJL Partners?
Quality Manager
Location: Hawthorne, CA (On-Site)
Compensation: $150,000 Base Salary Bonus Comprehensive Benefits 401(k) Match
About the Company
We are a growing and innovative medical device manufacturer dedicated to developing high-quality products that improve patient outcomes. Our team is committed to operational excellence, regulatory compliance, and continuous improvement throughout the product lifecycle.
We are seeking an experienced Quality Manager to lead our Quality Management System (QMS) and ensure compliance with FDA regulations, ISO standards, and industry best practices. This is a highly visible leadership role with significant impact across manufacturing, engineering, and product development.
Position Summary
The Quality Manager will be responsible for overseeing and continuously improving the company's Quality Management System (QMS), ensuring compliance with FDA regulations, ISO 13485, and other applicable standards. This individual will partner closely with Manufacturing, Engineering, R&D, and Regulatory Affairs to drive quality initiatives and maintain a culture of compliance and continuous improvement.
Key Responsibilities
- Lead and maintain the Quality Management System (QMS) in accordance with FDA regulations, ISO 13485, and other applicable standards.
- Manage internal audits, supplier audits, customer audits, FDA inspections, and ISO certification audits.
- Oversee CAPA, nonconformance, deviation, and complaint handling processes.
- Drive root cause investigations and implement effective corrective and preventive actions.
- Partner with Manufacturing, Engineering, Regulatory Affairs, and R&D to ensure quality is integrated throughout the product lifecycle.
- Develop, track, and report quality metrics and KPIs to executive leadership.
- Lead quality training initiatives and promote quality best practices across the organization.
- Manage document control, change control, risk management, and quality records.
- Ensure compliance with design controls, process validation, and manufacturing quality requirements.
- Supervise and mentor Quality Assurance and Quality Control personnel.
- Support continuous improvement initiatives to enhance product quality, efficiency, and compliance.
Qualifications
- Bachelor's degree in Engineering, Life Sciences, Quality, or a related field.
- 5 years of quality management experience within the medical device industry.
- Strong knowledge of FDA Quality System Regulations (QSR) and ISO 13485 requirements.
- Experience managing CAPA, nonconformance, complaint handling, and audit programs.
- Working knowledge of ISO 14971 risk management principles.
- Proven experience supporting FDA inspections and third-party audits.
- Demonstrated leadership experience managing quality teams.
- Strong communication, organizational, and problem-solving skills.
- ASQ certifications such as CQE or CQA are a plus.
Compensation & Benefits
- $150,000 Base Salary
- Performance-Based Bonus
- Comprehensive Medical, Dental & Vision Coverage
- 401(k) Plan with Company Match
- Paid Time Off and Holidays
- Career Growth Opportunities
- Collaborative and Mission-Driven Culture
If you are passionate about quality, compliance, and building world-class medical devices, we encourage you to apply.
Salary : $150,000