Senior Quality Assurance Manager

Job Title: Senior Quality Manager

Location: Orange County, CA

Salary: $130,000 - $155,000

We're looking for a Senior Quality Manager to oversee our Quality Systems, including the Quality Assurance and Technical Investigations Group (TIG). This is a high-impact role where you'll 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:

Bachelor's 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.