Director of Quality Assurance
1 day ago
At MRINetwork Jobs, we are seeking a highly skilled and experienced Director of Quality to join our team. As a critical leadership role, this position will oversee the comprehensive quality, compliance, and operational excellence of medical devices and drug products.
Key Responsibilities:
- Serve as the primary point of contact for all quality-related activities, including regulatory compliance, document control, CAPAs, complaints, NCMRs, deviations, risk management, supplier quality, design control, and internal and external audits.
- Maintain and enhance a comprehensive quality management system (QMS) to ensure alignment with cGMP and other regulatory requirements across both clinical and commercial operations for FDA-regulated medical devices and drugs.
- Develop and implement quality systems and SOPs for device and drug quality management, ensuring alignment with cGMP and other regulatory standards.
- Oversee all Quality Engineering functions, ensuring that devices and drugs are designed and manufactured in compliance with applicable FDA regulations (21 CFR Parts 820, 210/211) and ISO standards (ISO 13485, ISO).
- Lead supplier quality management for devices and drugs, managing the entire process from selection and onboarding to ongoing performance evaluations of contract manufacturers and other suppliers.
- Direct design control activities, managing robust process validation, risk management, and ensuring compliance from concept through post-launch.
- Act as a subject matter expert in design quality and risk management.
- Coordinate cross-functional collaboration with Operations, Engineering, Drug Development, and R&D to integrate quality considerations throughout product development and manufacturing processes.
- Lead and manages post-market surveillance, including device investigations for complaints and field actions.
- Lead the quality assurance team, responsible for hiring, mentoring, and overseeing staff development as the company expands.
- Develop and manage quality metrics to monitor performance, inform management decisions, support continuous improvement initiatives, and prepare regulatory submissions for product approvals.
Qualifications:
- Bachelor's degree in Engineering, Life Sciences, Chemistry, Chemical Engineering, or a related technical discipline; Master's degree preferred.
- Minimum of 10 years of experience in quality roles within the medical device and/or pharmaceutical industry, with significant leadership experience including managing supplier quality and quality assurance teams across devices and drugs.
- Comprehensive knowledge of FDA and international regulatory standards applicable to medical devices and pharmaceuticals, including 21 CFR Parts 820 and 210/211, ISO standards, and ICH guidelines.
- Proven track record in managing quality systems, ideally in a startup environment, and leading comprehensive quality functions.
- Strong leadership skills, with the ability to mentor and develop teams.
- Excellent problem-solving, organizational, and communication skills.
Preferred Qualifications:
- Certification as a CQE, CRE, Manager of Quality, and/or Six Sigma Black Belt.
- Experience in Human Factors/Usability Engineering and reliability engineering.
- Previous supervisory experience and a track record of effective team management.
- Familiarity with Arena (electronic quality management system).
- Familiarity with PMS for combination products including MDR.
Travel Requirements:
Travel may be required for about 10% of the time to support key contract manufacturing operations.
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