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. 
 
Position description:
The onsite Quality Management System (QMS) Manager is responsible for maintaining, improving, and ensuring the compliance of the Torrance (CA) facility’s Quality Management System for Class I medical devices. This position leads the Quality Assurance Inspection and Quality Engineering teams, drives continuous improvement activities, and partners closely with cross-functional teams to uphold product quality and customer satisfaction. 
Although medical device regulatory experience is not required, the QMS Manager will be expected to develop foundational understanding of U.S. FDA, Health Canada, and EU MDR requirements for Class I devices, with support and training provided. This position reports to the Director of QA/RA, North America Mobility, with dotted line reporting to the Site Leader/CFO.
 
Tasks and responsibilities:
Quality System Oversight:  Maintain and continuously improve the QMS in alignment with ISO 13485 and applicable regulatory expectations (training provided). 
Ensure adherence to internal quality policies, procedures, and global company standards. 
Monitor regulatory or standard changes and support updates to QMS documentation. 
 
Audit & Compliance: Lead internal audits and coordinate external audits from corporate, regulatory, or third party entities. 
Prepare and manage audit readiness activities and post?audit responses. 
Support regulatory documentation, registration maintenance, and compliance activities for the U.S., Canada, and EU as applicable to Class I devices. 
 
Personnel Management: Provide daily leadership for the Quality Assurance Inspection team. 
Manage Quality Engineering activities, prioritizing workload and coaching team development. 
Build a high performing, engaged quality team through clear expectations, mentorship, and performance management. 
 
Documentation & Training: Oversee document control systems, change management, training records, and quality documentation. 
Ensure compliant product labeling, traceability, and packaging documentation. 
Develop and maintain training content related to QMS processes and quality standards. 
 
Inspection, Measurement & Technical Quality Support: Ensure proper use and maintenance of manual measurement tools such as calipers, micrometers, height gauges, and pin gauges. 
Support inspection processes for incoming materials, in?process assemblies, and final products. 
Assist in developing inspection plans and criteria using engineering drawings and GD&T principles. 
 
Nonconformance & CAPA Management: Oversee investigations and resolution of nonconformances (Complaints, NCRs, CAPAs, SCARs). 
Lead the full CAPA lifecycle, ensuring timely closure, root-cause rigor, and effectiveness verification. 
 
Complaint & Incident Handling: Coordinate complaint management, investigation, and trend analysis for continuous improvement. 
Support Medical Device Reporting (MDR), Corrections & Removals (recalls), and related processes for Class I devices (training provided). 
 
Cross-Functional Collaboration: Work with Operations, R&D, Supply Chain, and Customer Service to meet quality and business objectives. 
Provide quality input during new product introductions, engineering changes, and process validation activities. 
Support global Regulatory & Quality requirements for products manufactured at the Torrance location 

Industry Engagement: Maintain awareness of industry best practices, relevant standards, and evolving regulations. 
Support internal initiatives to improve QMS maturity and operational efficiency. 
 
Candidate Profile:
Minimum 5 years of experience managing or supervising quality systems (ISO 9001 or ISO 13485 preferred). 
Medical device experience is beneficial but not required; willingness to learn Class I regulatory requirements is essential. 
Minimum 3 years of people leadership experience. 
Experience conducting audits and supporting external regulatory or customer audits. 
Strong knowledge of QMS processes such as document control, training, CAPA, complaint handling, risk management, and change management. 
Experience collaborating cross?functionally in manufacturing or product development environments; international experience is a plus. 
Hands?on experience with manual inspection tools (calipers, micrometers, etc.) and reading engineering drawings (GD&T). 
 
Skills and Work Style:
Detail-oriented with strong organizational and analytical skills.
Effective communicator with ability to work cross-functionally.  
Strong personnel management skills, with focus on coaching and mentoring. 
Proactive and self-motivated with a continuous improvement mindset.  
Comfortable working in a regulated environment with minimal supervision.  
Collaborative and positive team player. 
A strong interest and understanding of the products, customer and user needs and business requirements. 
 
Education:
Bachelor’s degree in Engineering, Life Sciences, Quality, or related field.
Certification in Quality Management (e.g., ASQ CQA, CQE) 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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