AP Professionals has partnered with a medical device manufacturer seeking a Director of Regulatory Compliance/Quality Assurance to join their Rochester, NY team. The Director of Regulatory Compliance/Quality Assurance will lead quality organization and be the main point of contact for audits. Ensure the promotion of awareness of applicable regulatory requirements and Quality Management system requirements throughout the organization. This company offers competitive pay and benefits!
- Responsible for the Quality Assurance and Regulatory Compliance functions for the facility.
- Ensures the promotion of awareness of applicable regulatory requirements and Quality Management system requirements throughout the organization.
- Ensures that the processes needed for the Quality Management System are established, implemented and maintained.
- Contributes to the achievement of company objectives by playing an active role in the strategic planning process including the development of quality targets and long range strategic plans (LRSP) for continuous quality improvement.
- Defines quality objectives and functional responsibilities.
- Monitors progress of the Quality KPI’s in achieving the Quality LRSP and communicate it to the organization and senior management.
- Interfaces with the manufacturing organization to analyze the effectiveness of the Quality Management System (eQMS).
- Ensures that the performance of the Quality Management System including performance against quality policy objectives is reported to senior management including any areas of improvement.
- Determines and enforces through functional groups quality requirements in accordance with current regulations and customer requirements.
- Contributes to the quality improvement efforts of the company by following a structured continuous improvement approach, and focusing on root cause identification and correction.
- Integrates quality and regulatory planning, in collaboration with Global Regulatory, with the planning for new or modified materials, products, components, equipment, and processes.
- Oversees FDA and ISO inspections and any external audits/assessments to ensure that the facility Quality Management System is properly represented.
- Serves as the facility Management Representative.
- Serves as the Recall Coordinator and executes recall reporting to FDA.
- Represents the facility in the World-Wide Quality Assurance team (WWQA) and supports the corporate/legal RA/QA functions.
- Serves as a facilitator and mentor to subordinators and fellow co-workers.
- Responsible for overall staffing, planning, training, and employee relations to achieve departmental objectives and key performance indicators, while following SOP and ISO requirements. As required hires, terminates, evaluates and disciplines employees in accordance with current personnel policies, including performance management and performance improvement plans. Regularly leads and monitors employee’s performance to assure that departmental goals and objectives are met. Ensures that staff is adequately trained and responsive to end user needs.
- Bachelors’ Degree preferable in Science or Engineering; or an equivalent combination of education and experience
- Minimum of 8-10 years’ of relevant professional experience in the medical device or pharmaceutical industry, preferably in a Manufacturing/Distribution environment.
- Experience working in a team environment, and proven ability to provide guidance that will promote good communications, objective thinking, and cooperation among different teams
Knowledge, Skills, Abilities, and Other Characteristics
- Proven ability to effectively contribute to the quality improvement efforts of the company
- Proven experience in establishing procedures for maintaining high standards of product quality and reliability
- Strong knowledge of FDA and international regulations
- Extensive experience in the regulatory compliance area
- Experience as lead contact point for regulatory agencies within a manufacturing operation
- Solid knowledge of Microsoft Office Suite