This position is responsible for the overall leadership of the Quality Team and ensuring that Transonic’s Quality Management System is managed in accordance with the various external regulations and standards that drive us (e.g. ISO 13485 Quality Management System, Medical Device Single Audit Program (MDSAP), EU MDR 2017/745 Regulation, and other applicable country regulations). The position is key to ensuring that a quality-based mindset is propagated throughout our organization. The Quality Team handles administration of our QMS, which includes ECO management, CAPAs and Failure Investigations, NCMRs, Failure Analysis and Supplier Management, Complaints & Reportability/Vigilance activities, Incoming Metrics and Inspection, Material Safety and SDS, Calibration & Maintenance of Devices, Quality Metric monitoring & reporting, Management Review, Declarations of Conformity sign-off, and Internal/External Audits. The Director of QA needs to be willing to learn the processes and procedures of these roles so that they can provide appropriate leadership, guidance, prioritization, and backup, as well as lead the cross-functional training efforts.
Duties and Responsibilities
- Drive continuous improvement in quality and compliance through quality metrics (e.g., customer complaints, product deviations, rework, scrap, warranty failures, and supplier quality metrics).
- Directly manage, monitor, and mentor the Quality staff in each of the Quality Processes previously noted to ensure their performance is effective, and support product development activities with guidance and methods that result in improved product quality, compliance, and speed to market.
- Ensure compliance of Quality Management System with all relevant Food and Drug Administration (FDA) and other international regulations, ISO 13485 and other appropriate standards, and internal corporate procedures and policies.
- Coordinate Management Reviews with the Regulatory team regarding quality data trends and quality system compliance with applicable regulations and standards.
- Provide leadership during external audits with notified bodies, regulatory agencies, and OEM clients to ensure findings/observations are properly documented and corrective actions are efficiently and effectively taken.
- Act as Transonic’s Management Representative with the responsibilities and authorities laid out within our quality manual and the applicable standards and guidance documents.
- Responsible for tracking and providing necessary updates to notified bodies on changes to products and the quality system, as well as reportable complaint notifications in conjunction with the Regulatory Affairs team.
- Responsible for quality reviews of sterile products and yearly sterilization supplier requalification
- Responsible for final sign-off of Engineering Change Orders, Deviations, Complaints, Failure Investigations/Failure Analysis, Post-Market Surveillance Plans & Reports, Clinical Evaluation Plans & Reports, Supplier Quality Plans/Agreements
Education and Experience
- BS in Engineering or related field.
- 5-10 years of experience in medical devices, preferably Class IIa/III (EU), Class II (FDA)
- Experience in managing a Quality team, preferably in medical device.
- Experience successfully managing cross-functional projects.
- Experience in audits, both internal and external.
- Experience with:
- Using quality methods to drive continuous improvement in product quality
- Driving quality initiatives that improve product quality, customer satisfaction, and QA/RA compliance.
- Statistical Process Controls (SPC)
- Experience with:
- ISO 13485
- EU MDR Requirements
- FDA’s 21 CFR and GMP Requirements
