AGSI
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. Key Responsibilities : Manage final product release, CAPA programs, QMS document control, validations, audits, complaints, change notifications, and non-conformances. 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 prepare 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 product, process, and quality system improvement initiatives. Deliver training and 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 insights and leading CAPA strategies for improvement. Qualifications : Bachelor's Degree. At least 1 year of auditor experience preferred. Hands-on experience in regulated medical device manufacturing. Knowledge of U.S. and international medical device regulations (e.g., 21 CFR 820, 803, 804, ISO 13485, ISO 14971, EU MDR, Canadian and Brazilian regulations). Formal training in quality tools such as CQE, CQA, Six Sigma, Risk Assessment, FMEA, FTA, DOE, and Statistical Techniques. Experience with process and equipment validation, method validation, process investigations, and technical evaluations.
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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. Key Responsibilities : Manage final product release, CAPA programs, QMS document control, validations, audits, complaints, change notifications, and non-conformances. 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 prepare 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 product, process, and quality system improvement initiatives. Deliver training and 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 insights and leading CAPA strategies for improvement. Qualifications : Bachelor's Degree. At least 1 year of auditor experience preferred. Hands-on experience in regulated medical device manufacturing. Knowledge of U.S. and international medical device regulations (e.g., 21 CFR 820, 803, 804, ISO 13485, ISO 14971, EU MDR, Canadian and Brazilian regulations). Formal training in quality tools such as CQE, CQA, Six Sigma, Risk Assessment, FMEA, FTA, DOE, and Statistical Techniques. Experience with process and equipment validation, method validation, process investigations, and technical evaluations.
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