About Carlsmed
Our mission is to improve outcomes and decrease the cost of healthcare for spine surgery. The Carlsmed aprevo® personalized surgery platform is designed to improve the standard of care for spine surgery one patient at a time.
Position Description
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.
Key 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.
Qualifications
- 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
- ASQ or ISO 13485 lead auditor certification preferred
- 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.
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.
Compensation
The anticipated annual base salary range for this position is $115,000 - $135,000. Individual compensation is determined based on factors such as experience, skills, education, certifications, and geographic location.
In addition to base salary, eligible employees may participate in incentive compensation programs and receive a comprehensive benefits package. Our benefits reflect our commitment to the health and well-being of our employees and their families and include 100% employer-paid medical, dental, and vision insurance premiums, a 401(k) plan with employer matching, and unlimited paid time off (PTO). Your recruiter can provide additional details about our total rewards package during the hiring process.
