The Quality and Regulatory Affairs Senior Director is responsible for providing strong leadership to the quality organization, as well as be a member of the business leadership team. The quality function is responsible for the maintenance and development of a multi departmental quality system that complies with ISO 9001, ISO 13485, as well as FDA QSR and associated requirements. This individual serves as the Management Representative and primary contact with ISO 9001/13485 registrars, as well as FDA and other regulatory agencies.
- Fosters a quality culture to achieve site-wide program success through measurable activity, metrics, and strong ability to influence teams in the areas of focus.
- Manages multiple departments responsible for quality systems, product quality, regulatory affairs and document control.
- Oversees the quality management system to ensure it is suitable, adequate and effective to support all applicable FDA Quality System Regulations, ISO 9001, ISO 13485, and the IVD Directive.
- Responsible for effective internal audit program, management reviews, operation procedure development, continuous improvement of the QMS and training of personnel on the quality system processes.
- Coordinates external audits for ISO registration, as well as FDA inspections; coordinate responses to customers’ supplier questionnaires.
- Responsible for the CAPA and complaint handling systems, and maintains quality metrics related to product/process quality and customer allegiance.
- Responsible for medical device regulatory affairs function and activities, including device, labeling and promotional reviews, regulatory submissions, and complaint reviews. Manages and maintains relationships with global partners to achieve international medical device registrations.
- Responsible for product compliance including electrical and mechanical safety, EMC, RoHS/REACH compliance, transportation safety and dangerous goods assessment.
- Drives consistent adoption of Quality Tools across the division, including 8D Corrective Action, Error Proofing, Failure Modes and Effects Analysis (FMEA), Design for Manufacturability (DFM), Statistical Process Control (SPC), Design Validation and Process Validation testing (DVT/PVT), and Critical to Quality (CTQ) documentation.
- Impacts product quality and compliance for assigned products, working with Operations, R&D and Product Support teams affecting warranty costs, instrument installations, and customer allegiance. Failure to perform could result in loss of ISO 9001 and/or ISO 13485 registration or FDA warning letters.
- Determines priorities for projects regarding maintenance and improvement of site-specific systems; recommends priorities and actions for those controlled by outside resources (such as division or corporate IT systems) affecting the local quality system.
- Has the necessary independence and authority within the organization, and through reporting relationships to initiate actions as needed to ensure the safety and efficacy of the medical products.
- Other miscellaneous duties as assigned.
- Bachelors Degree in Engineering or related scientific discipline; MBA or advanced engineering or scientific degree is preferred.
- Minimum 10 years experience in Quality Assurance management and leadership, preferably in Medical Device environment.
- Minimum 3 years in a Quality Leadership Role in a medical device company or other highly regulated industry such as aerospace or automotive. Experience in a startup environment is a plus.
- 3+ years experience in Lead Auditor role desired.
- Strong project leadership capability and ability to drive culture change. Working knowledge of ISO 13485/QSR requirements. Experience working in a six sigma or TQM manufacturing environment.
- Regulatory Affairs Certification desirable.
- Experience as the lead liaison for FDA and ISO audits/inspections.
- Extensive knowledge and experience in validation process design and process validation, change control, and auditing quality management systems.
- Experience working with a broad range of people from manufacturing personnel to senior management.
- Experience in product development software and hardware quality systems and audits.
- Experience in 21 CFR 11, 21 CFR 820, CE/IVD and ISO 13485 standards.