Careers - OsteoNovus. Breakthrough bone regeneration.
Breakthrough bone regeneration
Director of Quality Assuranceat our lab in Toledo, Ohio
In this role, the candidate is responsible for overseeing and leading the teams responsible for Risk Management activities, Reliability Engineering activities, and Compliance Engineering activities.
For the Compliance Engineering activities, they include but are not limited to the expert interpretation and application of the various industry standards and the requirements of the Medical Device Directive (MDD) to commercially develop and distribute product globally.
He/she will serve as a liaison between the company and the notified body for CE mark activities.
Deployment, maintenance, and execution of a world class medical device quality management system for industry standard compliance and interpretations, for example Alarm Standards for Medical Devices.
Provide leadership on the satisfaction of the implementation of ISO 14971:2012 Risk Management Standard expectations.
Provide expertise and guidance in interpreting US and foreign governmental regulations, agency guidelines, and internal/corporate policies to ensure compliance is maintained.
Work in close collaboration and partner with other departments and functions, including manufacturing, Regulatory, Supply Chain, Research & Development, and Clinical to optimize overall operational efficiency and effectiveness while maintaining best in class quality systems.
Provide leadership oversight to the Reliability Engineering, Compliance Engineering, and the Risk Management teams. Coach and mentor the leaders of those respective teams.
Administer and oversee the program and process of industry standard interpretation and application for Medtronic Diabetes product categories and types.
Participate in the support of the execution of external regulatory audits and inspections.
Participate with peers in the formulation of overall direction, processes, systems and talent development for the Quality organization.
Ensure current methods and tools are integrated into the Risk Management and Reliability Engineering processes and activities.
Perform other related duties as assigned.
Bachelor’s degree in a technical or scientific field
Minimum of 7 years’ experience in engineering, quality and/or regulatory for medical devices
Minimum 5 years’ management experience in a complex environment
Comprehensive knowledge of GMP and ISO 13485:2003 regulations, product design, manufacturing, supply chain, and distribution processes.
Broad understanding of US and International regulations including 21 CFR, 820
Influence management skills; demonstrated ability to work constructively across all functions of the organization
Experience presenting, interacting, and building effective relationships with regulatory agencies
Excellent communication and presentations skills (articulate and persuasive)
Strong team management and leadership skills. Ability to create strategies, define and articulate clear role expectations and direction. Ability to translate quality initiatives into specific objectives, metrics, and action plans
Willingness to “do what it takes,” including direct auditing activities at times
Ability to attract, develop, and retain diverse talent
Proven experience in achieving results through influence management and motivating teams