Develop, implement and lead the Company’s quality, regulatory, and compliance efforts aligned with the overall mission and goals of the organization and integrated with clinical, operations and marketing efforts. Serve as the company’s Management Representative, and lead contact (Qualified Person) for regulatory agencies and Notified Bodies.
- Plan, design, and implement a comprehensive quality system that complies with relevant FDA GMP Design Control and ISO 13485 regulations appropriate for the Company’s products
- Lead the implementation of the QMS and work co-operatively with R&D, marketing, operations, and others within the company to drive improvements in customer satisfaction, productivity, regulatory compliance, and company efficiency
- Plan, execute and manage quality assurance systems and activities including quality engineering, product release, CAPA/Non-conforming system, complaint investigation, document control and training systems, ensuring compliance with regulatory and company requirements
- Serve as the site host during 3rd Party audits, i.e. Notified Body, FDA and other regulatory agency compliance inspections and coordinate responses.
- Maintain strong relationships with regulatory agencies, competent authorities and standards organizations which impact the Company
- Manage and maintain the internal and supplier audit system, the corrective/preventive action system, the control nonconforming material system, complaint system, document control system and others as required
- Work closely with other departments to ensure projects conform to all regulatory and quality requirements
- Assure the plant is compliant with cGMP regulations and is maintained in an inspection-ready status
- Implement proactive quality programs to prevent compliance problems, reduce losses, and assure timely release of products
- Assist in preparation of reports, summaries, and other data to support product and establishment regulatory submissions;
- Coordinate and facilitate periodic Management Review to inform management of compliance risks, improvements and current status of the Quality System
- Provide quality training to site staff and new hires in the use of the quality system and associated regulations
- Ensuring the promotion and awareness of regulatory and customer requirements throughout the organization
- Ensuring VitalConnect operates in compliance with state, federal, and international laws and regulations governing the manufacture and distribution of medical devices
- Reviewing technical problems and procedures and recommending solutions
- Ensuring representation of Quality Assurance at design and development meetings
- Bachelor’s degree preferred
- Degree in life sciences or engineering preferred
Knowledge and Training
- A minimum of 15 years experience in quality operations in the Medical Device industry and a minimum of 10 years supervisory experience.
- Knowledge and competency in application of FDA, ISO 13485, ISO 14971, MDD, MDR, and other regulatory requirements, especially in the area of Quality Systems and Design Control as applied to projects from design inception to manufacturing release, is required.
- Solid understanding and relevant experience in software/hardware/mechanical design verification and validation methods.
- Ability to balance the needs of a fast paced start-up environment with the needs for good documentation and quality control.
- Experience in implementing and managing documentation/configuration control systems.
- Experience with FDA/ISO design control audits.
- Experience with the following techniques; Hazard Analysis, Risk Analysis, FMEA.
- Quality systems implementation and maintenance experience required.
- Demonstrated abilities in building and leading cross-functional/cross-site teams, time and budget management, influencing and working well with others in a proactive and constructive manner, and communicating clearly, in both verbal and written forms, within all levels of the organization is required.
- Experience preparing and executing training programs, internal and vendor quality auditing, and interactions with regulatory agencies and customers in inspections and audits.
- Experience with all phases of the product development lifecycle, including concept, design, implementation, verification, and validation activities necessary for product commercialization
- Experience in cGMP and other Regulatory compliance requirements
- Hands on experience with FDA Federal and State Audits