Senior Quality Assurance Manager

Get AI-powered advice on this job and more exclusive features.

Innovative Career Resources & Staffing provided pay range

This range is provided by Innovative Career Resources & Staffing. Your actual pay will be based on your skills and experience talk with your recruiter to learn more.

Base pay range

$130,000.00/yr - $160,000.00/yr

Direct message the job poster from Innovative Career Resources & Staffing

Were looking for a Sr. Quality Manager to oversee our Quality Systems, including the Quality Assurance and Technical Investigations Group (TIG). This is a high-impact role where youll lead a talented team and champion initiatives that ensure excellence across every facet of our operations.

Just a snapshot of what you will manage:

• Final product release
• CAPA programs
• QMS document control
• Validations
• Internal & external audits
• Complaints & change notifications
• Non-conformances

Key Responsibilities Quality Leadership Role:

• Lead and manage all aspects of the Quality Systems, ensuring compliance and continuous improvement.
• Serve as a subject matter expert on quality regulations, including GMP and ISO standards.
• Oversee and direct preparation for FDA and Notified Body inspections, acting as the primary quality liaison.
• Coordinate and host internal and external audits, ensuring audit readiness and successful outcomes.
• Drive and support product, process, and quality system improvement initiatives across the organization.
• Deliver training and hands-on coaching on Quality System Regulations, ISO standards, and compliance best practices.
• Develop and lead the Quality Systems team including hiring, mentoring, performance management, and growth planning.
• Monitor and analyze Quality Indicators and KPIs, providing actionable insights and leading effective CAPA strategies for ongoing improvement.

We're Looking For Must-Have Qualifications:

• Bachelors Degree.
• Auditor experience at least 1 year preferred.
• Hands-on experience in a regulated medical device manufacturing environment.
• Solid understanding of U.S. and international medical device regulations, including: 21 CFR 820, 803, 804 (MDR), ISO 13485, ISO 14971, ISO 13408, EU MDR 2017/745 / MDD 93/42/EEC, Canadian and Brazilian Medical Device Regulations.
• Formal training in quality tools such as CQE, CQA, Six Sigma, Risk Assessment, FMEA, FTA, DOE, and Statistical Techniques.
• Experience with validation of processes and equipment, method validations, process investigations, and technical evaluations.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management, Quality Assurance, and Strategy/Planning

• Industries

  Medical Equipment Manufacturing and Biotechnology Research

Referrals increase your chances of interviewing at Innovative Career Resources & Staffing by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Get notified about new Quality Assurance Manager jobs in Irvine, CA .

Quality Assurance (QA) Manager - SaaS Learning Platform

Irvine, CA $90,000.00-$120,000.00 2 weeks ago

Newport Beach, CA $113,000.00-$158,000.00 6 days ago

Santa Ana, CA $130,000.00-$150,000.00 5 days ago

Newport Beach, CA $113,000.00-$158,000.00 1 hour ago

Brea, CA $85,000.00-$110,000.00 2 months ago

Santa Ana, CA $100,000.00-$100,000.00 6 days ago

Irvine, CA $77,760.00-$143,920.00 5 days ago

City of Industry, CA $120,000.00-$150,000.00 3 weeks ago

Cypress, CA $85,000.00-$95,000.00 3 weeks ago

Irvine, CA $118,500.00-$160,100.00 6 days ago

Irvine, CA $88,800.00-$133,200.00 3 weeks ago

Santa Ana, CA $90,000.00-$110,000.00 1 month ago

San Clemente, CA $100,000.00-$110,000.00 4 days ago

Supervisor Laboratory Services, Full-time, Days Shift (8 Hours)

Long Beach, CA $140,000.00-$160,000.00 1 week ago

Irvine, CA $120,000.00-$170,000.00 1 month ago

Assurance Manager, Quality Management - IS Assurance

Laboratory Technician I - Metals Prep, Eurofins Environment Testing Calscience, Tustin, CA

Paramount, CA $90,000.00-$110,000.00 5 days ago

Long Beach, CA $190,000.00-$230,000.00 1 week ago

Santa Ana, CA $65,000.00-$90,000.00 1 month ago

Santa Ana, CA $110,000.00-$140,000.00 2 weeks ago

Laboratory Technician II (M-F, 1pm -10pm) Organic Prep, Eurofins Environment Testing Calscience, Tustin, CA

Irvine, CA $96,000.00-$186,000.00 4 days ago

Building Automation Controls Account Manager

Irvine, CA $70,000.00-$125,000.00 1 month ago

Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.