Senior Quality Systems Manager

Michael Page; Irvine (CA); On-site; USD 150,000 - 165,000; Full time

Benefits offered by this job

401k

Job summary

A leading global medical device company in California is seeking a Senior Quality Systems Manager to oversee compliance and quality systems. You will lead audits, drive process improvements, and manage a quality team in a regulated environment. Candidates should have a bachelor's degree and experience in medical device manufacturing. This full-time role offers a competitive salary and benefits.

Qualifications

• Experience in a regulated medical device manufacturing environment.
• Strong knowledge of ISO 13485, FDA QSR, and EU MDR.
• Experience in audits, CAPA, and validation processes.

Responsibilities

• Lead and manage quality systems ensuring compliance.
• Oversee audits and FDA inspections.
• Drive process improvement initiatives.

Skills

Quality regulations and standards

Analytical skills

Problem-solving skills

Communication skills

Education

Bachelor's degree preferred

Job description

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Michael Page provided pay range

This range is provided by Michael Page. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$150,000.00/yr - $165,000.00/yr

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.

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.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

• Management, Manufacturing, and Quality Assurance

Industries

• Manufacturing, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing

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