Carlsmed
Associate Quality Assurance Manager
Carlsbad, California · Director
Sponsorship not specified$115k-$135kDetected 40 days ago
FDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationMentoringMicrosoft OfficeRegulatory Affairs
About the role
- Equal Opportunity Employer Carlsmed is an equal opportunity employer.
Responsibilities
- Support and maintain the Quality Management System (QMS) to ensure compliance with FDA 21 CFR Part 820, ISO 13485, MDSAP, and other applicable regulatory requirements.
- Manage quality system processes, including nonconformance management, CAPA, change control, supplier management, trending analysis and quality records.
- Develop and update processes to improve effectiveness and efficiency.
- Support internal and external audits, regulatory inspections, and supplier audits, ensuring timely resolution of audit findings.
- Lead investigations and quality improvement activities, including root cause analysis, corrective and preventive actions (CAPA), and effectiveness verification.
- Monitor quality metrics and trends, analyze data, and provide recommendations to management to drive continuous improvement and regulatory compliance.
- Partner with cross-functional teams including Regulatory Affairs, Operations, Manufacturing, Engineering, and Clinical Affairs to support product development, manufacturing, and post-market activities.
- Support supplier quality and risk management activities, including supplier qualification, performance monitoring, and quality issue resolution as needed.
Requirements
- Direct experience with managing quality system processes such as CAPA, non-conforming products, product release and supplier monitoring
- Experience in supporting regulatory inspection, internal and external audits
- Effective verbal and written communication skills, including the ability to present information to management and auditors.
- Strong interpersonal and collaboration skills with the ability to work effectively across cross-functional teams.
- Proficiency with electronic quality management systems (eQMS), Microsoft Office applications, and quality-related software tools.
- Bachelor degree in Engineering, Life Sciences, Quality Assurance or a related technical discipline or an equivalent combination of education and relevant professional experience
- ASQ or ISO 13485 lead auditor certification preferred
- Demonstrated leadership, coaching, and team development capabilities.
Nice to have
- Position Description
- Provide leadership, coaching, and training to quality personnel and employees on quality system requirements, procedures, and best practices.
- 5-8 years of experience in Quality Assurance within a regulated industry
- Strong working knowledge of ISO 13485, 21 CFR 820 and MDSAP process
Compensation
- We are pleased to provide a competitive salary and benefits.
- The expected pay range is $115,000 - $135,000.
- Compensation may vary based on related skills, experience, and relevant key attributes.
Equal opportunity
- Employer
- Carlsmed is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. Carlsmed is committed to providing reasonable accommodation for candidates with disabilities in our recruitment process. If you need assistance or accommodation due to a disability, please let us know.
- Carlsmed is an equal opportunity employer.
- All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.
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This listing is sourced directly from Carlsmed's careers page and normalized into a canonical job model.