This is an exciting time to join Spiration as the leader of our Quality department. Ours is a very team oriented and collaborative company, currently manufacturing and selling two products and developing several more. The Quality organization is a dynamic team of talented individuals committed to continuous improvement. We are looking to find the right leader to join the team and take the players and the systems to the next level.
The Director will be responsible for managing Quality Systems, Regulatory Compliance, and Quality Engineering activities to ensure compliance with medical device standards and regulations, which include: 21 CFR Part 820 Quality system Regulation (QSR), ISO 13485, 93/42/EEC Medical Devices Directive (MDD), and SOR/98-282 Canadian Medical Device Regulations (CMDR). In addition the Director, Quality Systems will support Manufacturing and Engineering functions in all phases of design, development, production and distribution of medical devices.
- Manage the implementation and optimization of the quality management system. Serve as company Management Representative, to ensure that quality management system requirements are effectively established and maintained in accordance with medical device regulations and international standards.
- Lead the development and execution of quality policy, quality objectives, and strategic quality plans.
- Oversee, supervise, and provide direction to a team of six working in the following areas:
- Document Control
- Receiving Inspection and Final Inspection
- Internal Quality Audits
- Corrective and Preventive Actions (CAPA)
- Complaint Handling
- Supplier Management
- Device History Record Review
- Employee Training
- Design History File Maintenance
- Equipment Control
- Risk Management Activities
- Quality Engineering
- Serve as Notified Body liaison, maintaining technical files of CE marked products and filing amendments to product files, as required.
- Serve as Authorized Representative liaison in the EU, providing support in areas of complaint handling and technical documentation.
- Serve as lead Spiration contact for inspections by regulatory agencies. Coordinate preparation activities and ensure the company maintains a state of readiness for inspections.
- Represent the Quality function on project teams, providing quality and regulatory compliance input, feedback, and guidance.
- Review and approve product and manufacturing changes via Document Change Notice (DCN) approval to ensure adherence to quality system requirements. As an alternate to the Director of Regulatory Affairs, assess the impact of changes on current clinical investigations and FDA filings.
- Review device labeling and advertising materials for compliance with US and international labeling regulations.
- Develop systems, implement and train employees on quality and regulatory requirements in areas including, but not limited to, management review; corrective and preventive actions; internal quality audits; post market surveillance/complaints; and recall/removals. Activities include the following:
- Create and revise quality system procedures, as required.
- Chair and coordinate quality management review meetings. Oversee action items associated with meetings, including actions associated with trending presented in meetings.
- Ensure completion of all corrective actions associated with the quality system and ensure that the CAPA process is in compliance with regulatory requirements.
- Perform internal quality audits according to the approved schedule. Manage audit processes including managing audit resources, tracking status of audit findings to closure, and audit record retention.
- Manage product complaint handling system.
- Oversee the implementation of applicable post market activities. Post market studies are conducted in conjunction with Clinical Affairs and Marketing.
- Assist Regulatory Affairs with filings of Vigilance reports and MDRs when required.
- Support the regulatory submissions made to FDA and other regulatory agencies (domestic and international) to obtain clinical and product approvals and respond to inquiries.
- Plan department budgets and manage expenses. Establish project priorities and allocate resources according to workload.
- Other responsibilities as requested may be assigned.