Quality Control Manager

Capstone Search Advisors is searching for a Quality Systems Specialist to oversee the development, implementation, and continuous improvement of the Quality Management System (QMS) to ensure compliance with FDA, ISO 13485, ISO 14971, EU MDR, and other applicable global medical device regulations.

This role will provide leadership in maintaining quality system processes, driving compliance, and fostering a culture of quality across the organization.

Key Responsibilities

Manage and maintain the company's QMS in compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable standards/regulations.

Lead the implementation, monitoring, and continuous improvement of quality system processes (Document Control, Training, CAPA, Nonconformance, Audits, Change Control, Complaints, Supplier Quality, etc.).

Ensure timely and effective execution of Corrective and Preventive Actions (CAPA) and provide oversight of root cause investigations.

Plan, coordinate, and lead internal audits; support external audits and regulatory inspections.

Oversee document control and training programs to ensure compliance and employee competence.

Partner with cross-functional teams (R&D, Manufacturing, Supply Chain, Regulatory, Clinical) to embed quality requirements throughout the product lifecycle.

Monitor and analyze quality metrics and provide regular reporting to senior management.

Ensure supplier quality management programs are compliant, including supplier qualification, audits, and performance monitoring.

Serve as the SME (Subject Matter Expert) for QMS processes during regulatory inspections and customer audits.

Mentor and develop quality team members, fostering a culture of compliance, accountability, and continuous improvement. Qualifications

Bachelor's degree in Engineering, Life Sciences, Quality, or related field

3+ years of quality experience in the medical device or related regulated industry

Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, and related global quality system regulations.

Experience leading audits (FDA, ISO Notified Body, MDSAP preferred).

Proven track record of managing CAPA, nonconformance, change control, and complaint-handling systems.

Excellent leadership, communication, and cross-functional collaboration skills.

Proficiency with electronic QMS platforms (eQMS) strongly preferred.

Opening Doors to Incredible Opportunities:

For over two decades, Capstone has been working with elite organizations from Fortune 500s to start-ups in some of the most competitive market sectors. Because of our deep connections, we're able to match you with the most relevant and prestigious career opportunities available - whether you're an executive or manager, we'll help you reach your professional goals.

Protect Yourself from Job Scams

We've seen an increase in scam attempts targeting job seekers. Please know that our team will never request sensitive personal information-such as your Social Security number or banking details-outside of our secure onboarding system. This system is the only method we use to collect the information necessary for employment.

All official communication will come from verified company email addresses or phone numbers. If something seems suspicious, trust your instincts and don't engage. Learn how to spot job scams and protect yourself here.

Equal Opportunity Employer:

Capstone provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. We celebrate diversity and are committed to creating an inclusive environment for all employees. Capstone will provide reasonable accommodations for people with disabilities in all parts of the hiring and employment process.