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Job Requirements of Senior Quality Systems Manager:
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Employment Type:
Full-Time
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Education:
4 Year Degree
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Location:
Irvine, CA (Onsite)
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Senior Quality Systems Manager
The Senior Quality Systems Manager will oversee all aspects of the company's Quality Systems, including compliance, audits, product release, and continuous improvement initiatives in alignment with FDA, ISO, and global regulations. This role also leads and develops the quality team while partnering cross-functionally to support operations, engineering, and overall business objectives.
Client Details
Our client is a global medical device manufacturer focused on delivering high-quality products that improve patient outcomes. They operate in a highly regulated environment and are committed to innovation, compliance, and continuous improvement across their operations
Description
- Lead and manage Quality Systems, ensuring compliance with regulatory and ISO requirements.
- Oversee internal and external audits, FDA/Notified Body inspections, and related readiness activities.
- Drive quality system and process improvement initiatives across the organization.
- Manage and develop the Quality Systems team, including coaching, training, and performance management.
- Analyze KPIs and quality metrics, recommending and implementing corrective/preventive actions.
- Provide training on quality regulations and systems to internal stakeholders.
Profile
- Bachelor's degree preferred.
- Prior experience in a regulated medical device manufacturing environment.
- Strong knowledge of quality regulations and standards, including ISO 13485, FDA QSR, EU MDR, and related international standards.
- Experience in audits, CAPA, and validation processes.
- Strong analytical, problem-solving, and communication skills.
- Ability to thrive in a fast-paced, dynamic environment with multiple projects.
Job Offer
- 401k
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.