Senior Quality Assurance Manager
Senior Quality Assurance Manager
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1 Vacancy
Job Description
Job Title: Senior Quality Manager
Location: Orange County CA
Salary: $130000 - $155000
Were 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 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.
Were 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(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.
QMS,Quality Systems Management,CAPA,Internal Audit,External Audit,Technical Investigations,Risk Management,Failure Mode and Effects Analysis (FMEA),FTA,Risk Assessment
Employment Type
Full Time
