Senior Quality Systems Manager | MedDevice

Located in Orange County, CA, this leadership role puts you at the forefront of quality and compliance in a regulated, innovation-driven environment. As the Senior Quality Systems Manager, you'll oversee all aspects of the Quality Management Systems, leading a high-performing team, collaborating across departments, and ensuring world-class standards that support growth and excellence.

Client Details

Join a global leader in life sciences and medical technology, dedicated to advancing healthcare through innovation and quality. With a strong presence in Orange County, CA, this organization is at the forefront of developing cutting-edge solutions that improve lives worldwide. Here, quality isn't just a department; it's the foundation of everything we do.

Description

• Lead and manage all aspects of the Quality Management System (QMS), ensuring compliance with global regulatory standards
• Oversee key activities including product release, CAPA, complaints, audits, investigations, validations, and non-conformance management
• Act as the primary quality resource and subject-matter expert for GMP, ISO, and FDA/Notified Body requirements
• Prepare for, host, and support regulatory inspections and audits with confidence and precision
• Champion continuous improvement initiatives at both the system and process level
• Train, mentor, and develop your quality team, driving engagement, growth, and performance excellence
• Track and analyze quality metrics (KPIs), providing insights that drive data-driven decisions and corrective/preventive actions
• Collaborate with manufacturing, engineering, and business teams to ensure quality standards support product lifecycle management and innovation

Profile

• Bachelor's degree (or equivalent experience) required; advanced training in quality tools a plus
• Experience working in a regulated medical device, biotech, or life sciences environment
• Strong working knowledge of global quality and regulatory standards (21 CFR 820, MDR, ISO 13485, ISO 14971, EU MDR, etc.)
• Prior auditor experience and exposure to FDA and Notified Body inspections preferred
• Proven track record of leading teams, managing QMS activities, and driving improvements
• Strong analytical, organizational, and communication skills with the ability to influence across teams
• A collaborative, detail-oriented leader who thrives in a fast-paced, high-impact environment

Job Offer

This is more than a job; it's an opportunity to join a mission-driven organization that is shaping the future of healthcare. You'll be empowered to lead, innovate, and make a meaningful impact every day, while working alongside some of the brightest minds in the industry.

Other Perks:

• Competitive salary and performance bonus
• Health, dental, and vision insurance
• 401(k) with company match
• Paid time off and holidays
• Professional development and training opportunities

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.