Director of Quality Assurance

A leading provider of medical solutions is seeking a leader for their Quality and Regulatory team. This role is responsible for overseeing all aspects of regulatory compliance and quality management, ensuring alignment with their mission to develop innovative products that address critical healthcare challenges worldwide. This is an exciting opportunity to play a pivotal role in shaping the quality and regulatory strategy of a growing medical solutions company.

Key Responsibilities

1. Lead, mentor, and develop the Quality and Regulatory team, setting strategic goals and providing guidance to ensure professional growth and success.
2. Oversee quality and product design engineering functions, ensuring proper use of materials, design controls, and compliance with industry best practices.
3. Manage and continuously improve the Quality Management System to maintain full audit readiness.
4. Direct customer complaint handling processes, ensuring efficient root cause analysis, resolution, and trend monitoring.
5. Supervise post-market surveillance and regulatory reporting in compliance with international and domestic requirements.
6. Provide strategic guidance on regulatory requirements, preparing and submitting necessary documentation.
7. Support the development and implementation of global regulatory policies.
8. Review and approve labeling, promotional materials, and product modifications for compliance with regulatory requirements.
9. Prepare and submit reports to regulatory agencies as needed.
10. Oversee quality assurance activities for new product development, ensuring adherence to design control procedures.
11. Support manufacturing teams in identifying and resolving quality issues, conducting failure analyses, and improving processes.
12. Manage supplier quality controls and work closely with operations to address quality concerns proactively.
13. Lead facility inspections by domestic and international regulatory agencies.
14. Stay up to date on evolving regulations, industry standards, and compliance requirements, providing insights on their impact on existing and new products.

Required Skills & Experience

1. Bachelor's degree in life sciences, engineering, or a related field (advanced degree preferred).
2. 10+ years of experience in the medical technology, healthcare, or life sciences industry, with at least five years in a quality or regulatory leadership role.
3. Hands-on experience with U.S. FDA regulations and audits.
4. Strong expertise in designing, implementing, and scaling quality management systems and risk mitigation strategies.
5. Knowledge of international and domestic regulatory requirements, including 21 CFR 820, ISO 13485, MDR, ISO 14971, and ISO 10993.
6. Proven ability to lead quality and regulatory teams in both U.S. and global markets.
7. Experience managing product lifecycle stages, from concept and design through validation, commercialization, and compliance.
8. Comfortable working in a fast-paced, dynamic environment, with the ability to adapt to shifting priorities while delivering results.
9. Ability to travel up to 30% as needed.

Seniority level

Director

Employment type

Full-time

Job function

Quality Assurance

Industries

Medical Equipment Manufacturing