Associate Quality Assurance Manager

Carlsmed•Carlsbad, CA

About The Position

The Associate Manager, Quality Assurance supports the development, implementation, and maintenance of the Quality Management System (QMS) to ensure compliance with applicable regulatory requirements and company quality standards. This role will support the Director of Quality Assurance with all quality assurance activities, including document control, audits, CAPA, nonconformance management, and continuous improvement initiatives, while collaborating cross-functionally to support product quality and regulatory compliance. The Associate Manager provides leadership and guidance to quality team members, drives quality objectives, and promotes a culture of quality throughout the organization.

Requirements

Bachelor degree in Engineering, Life Sciences, Quality Assurance or a related technical discipline or an equivalent combination of education and relevant professional experience
5-8 years of experience in Quality Assurance within a regulated industry
Strong working knowledge of ISO 13485, 21 CFR 820 and MDSAP process
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.
Demonstrated leadership, coaching, and team development capabilities.
Proficiency with electronic quality management systems (eQMS), Microsoft Office applications, and quality-related software tools.

Nice To Haves

ASQ or ISO 13485 lead auditor certification preferred

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.
Provide leadership, coaching, and training to quality personnel and employees on quality system requirements, procedures, and best practices.
Support supplier quality and risk management activities, including supplier qualification, performance monitoring, and quality issue resolution as needed.