Position Summary: The Director of Quality provides strategic leadership and oversight of the company's global quality systems, with direct responsibility for Quality Engineering at the Audubon (HQ) site, International Operations Quality, and Sterile Manufacturing Quality. This position ensures compliance with applicable regulatory requirements (FDA QSR, ISO 13485, EU MDR, MDSAP, etc.) and alignment with company objectives for product safety, effectiveness, and continuous improvement. The Director will collaborate cross-functionally with Manufacturing, Supply Chain, R&D, and Regulatory teams to maintain a culture of quality excellence and operational efficiency across all facilities and international markets.
Essential Functions:Leadership & Strategy
- Develop and execute the global quality strategy aligned with company objectives and regulatory requirements.
- Provide leadership, mentoring, and development for the Quality Engineering, International Quality, and Sterile Manufacturing Quality teams.
- Serve as a senior quality representative in management review, audits, and regulatory inspections.
- Drive a culture of accountability, continuous improvement, and proactive risk management.
Quality Engineering
- Oversee product quality engineering, including design assurance, process validation, risk management, and post-market feedback.
- Ensure robust CAPA, complaint handling, and nonconformance processes.
- Lead validation strategy and ensure compliance with ISO 14971, ISO 13485, and 21 CFR Part 820 requirements.
- Support new product development and design transfer to manufacturing.
International Operations Quality
- Oversee quality system compliance at all international manufacturing and distribution sites.
- Ensure adherence to global regulatory requirements including MDSAP, EU MDR, Health Canada, PMDA, and TGA.
- Harmonize global quality processes and drive consistency across regions.
- Support international audits and coordinate responses to regulatory authorities.
Sterile Manufacturing Quality
- Provide oversight of sterilization validation, monitoring, and requalification programs in accordance with ISO 11135 / ISO 11137 / ISO 17665.
- Ensure control of cleanroom operations, environmental monitoring, aseptic techniques, and contamination control programs.
- Approve sterilization cycles, validations, and deviations.
- Support product release and ensure compliance with sterility assurance requirements.
Audits, Compliance & Continuous Improvement
- Lead or support internal and external quality audits.
- Ensure timely closure of audit findings and CAPA actions.
- Implement continuous improvement initiatives to enhance quality system performance and product reliability.
- Monitor and report key quality metrics to executive management.
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Qualifications:- Minimum BS degree or equivalent in Science or Engineering. A relevant post-graduate qualification would be an advantage but not essential
- Minimum of 5 years of experience is needed within Medical Device Quality Assurance/ Quality Systems with experience in FDA and CE Notified Body inspections
- Experience in product quality assurance, process quality, verification and validation
- Experience with electro-mechanical medical devices, including software, is desired
- ASQ Certification or equivalent formal training and experience is desired. Multi-discipline assurance background is desired. Knowledge of Lean Manufacturing, Six Sigma, and reliability engineering is a plus
- Demonstrated knowledge and understanding of the Quality System Regulations (FDA) and standards, ISO 13485, and other related regulations with emphasis in problem solving and CAPA Systems
- Computer proficiency with MS Office and statistical analysis tools is required; Must be able to make solid decisions that effectively support the business and company policies
- Presentation skills and ability to train personnel in quality matters
- Travel requirements are as needed
Physical Demands:The physical demands listed here are representative of those that must be met by and employee to successfully perform the essential functions of this job.
- Required to sit; climb or balance; and stoop, kneel, crouch or crawl
- Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds
- Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus.
Other Duties:Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
