Quality Manager (Quality Systems Manager)  Torrance, CA
Our client, a medical device manufacturer (pioneer of the pediatric wheelchair), is currently hiring a Quality Manager (Quality Systems Manager), to fill some very big and important shoes- an individual retiring after 40 years (this could be you in 40 years).  A big goal for this company is to receive their ISO13485 certification.  This role will manage and  supervising quality systems within the medical device industry, Class I devices, experience with  ISO, FDA, Health Canada and EU MDR regulations.

The on-site Quality Management System (QMS) Manager will be responsible for overseeing and maintaining the QMS for Class I medical devices at our Torrance (CA) facility, in addition to management of Quality Assurance Inspection and Quality Engineering personnel. 

This role ensures compliance with applicable regulatory requirements, supports continuous improvement initiatives, and collaborates cross-functionally to uphold product quality and customer satisfaction. The QMS Manager reports to the Director of QA/RA, North America Mobility, with dotted line reporting responsibility to the Site Leader/CFO. 
 
Tasks and responsibilities:
Quality System Oversight – Maintain and continuously improve the QMS in alignment with ISO 13485 and applicable FDA and Health Canada regulations. 
Ensure adherence to internal quality policies, procedures, and global company standards. 
Monitor regulatory changes and update QMS documentation accordingly. 
 
Audit & Compliance- Lead internal audits and coordinate external audits from regulatory bodies and notified parties.
Prepare and manage audit readiness and responses.
Ensure regulatory submissions and registrations are completed for the US and Canada, and support.
European submissions in collaboration with regional teams. 
 
Personnel Management- Oversee and manage daily functions of Quality Assurance Inspection team. 
Oversee and manage daily functions of Quality Engineer .
 
Documentation & Training- Manage document control systems, training records, and quality documentation.
Ensure traceability and compliance in product labeling and packaging. 
 
Nonconformance & CAPA Management- Oversee timely nonconformance investigations and corrective/preventive actions (Complaints, NCR, CAPA, SCAR).
Lead CAPA lifecycle: initiation, tracking, resolution, and closure with cross-functional teams. 
 
Complaint & Incident Handling- Coordinate complaint management and trend analysis for continuous improvement.
Manage Medical Device Reporting (MDR) and Corrections & Removals (recalls) processes.
 
Cross-Functional Collaboration- Partner with Operations, R&D, and Customer Service to meet quality objectives.
Provide quality input during new product introductions and process changes 
Support global Regulatory & Quality requirements for products manufactured at the Torrance location 
 
Industry Engagement- Stay informed on industry trends and evolving regulatory requirements.
 
Qualifications:
Strong understanding of QMS requirements for Class I devices (Class I preferred, however, Class III, Class II or Class I medical device experience preferred).
Experience with ISO 13485, FDA 21 CFR Part 820, Health Canada, and EU MDR regulations.
Minimum 3 years of experience in employee management preferred.
Proven track record in managing audits and regulatory inspections.
Familiarity with complaint handling, product nonconformance and CAPA processes. 
Experience in managing quality processes covering R&D and New Product Introductions. 
Experience from working cross functionally and preferably international experience. 
Bachelor’s degree in Engineering, Life Sciences, Quality, or related field.
Certification in Quality Management (e.g., ASQ CQE, CQA) is a plus. 

Client is widely recognized for designing and manufacturing high-quality, specialized mobility products, especially lightweight, compact, and customizable wheelchairs for children and adults with special needs. Join a mission-driven company dedicated to making a positive impact on the lives of children with mobility challenges and their families. Team members contribute directly to creating life-changing assistive devices and solutions, which can be deeply rewarding. If you’re motivated by meaningful work, opportunities for innovation, and a caring, family-focused environment, this is the place for you, working here, you’ll feel you’re in a fulfilling place to build your career.

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