What will you do
Drive DMSI Andover Quality including implementation of and adherence to Quality Management System and Product Quality Performance. Assure compliance with all applicable regulatory standards and directives, establish and manage business specific quality targets, and develop necessary quality statistics and methodologies. Develop, implement and coordinate product assurance programs to prevent or eliminate defects in new and existing products to achieve quality targets.
Maintain compliance and continuously improve the DMSI Andover QMS in regard to ISO 9001, ISO 13485, CMDR SOR/98-282, MDD 93/42EEC and MDR 2017/745, and 21 CFR Part 820 and further regulatory requirements which apply to the Andover product portfolio.
Serve as the DMSI Andover focal point of contact with the Notified Bodies. Serve as the primary contact for FDA, T V, regulatory, and third party audits and inspections and/or preparation as necessary. Ensures that the cross-functional organization is aligned and prepared for audits and inspections.
Defines Quality Management goals and ensures alignment with other relevant business goals of Drger. Responsible for leading PQB and QMS Boards. Analyzes and reviews quality management goals and breaks down corresponding goals for the relevant product quality targets. Creates partnerships within Draeger to drive quality. Drives the achievement of the agreed upon targets to achieve business targets in both Quality and Process Performance. Refines and fosters a set of necessary quality statistics and methodologies.
Serves as the Management Representative for ISO 9001, ISO 13485, FDA, ISO 14001 and as Person Responsible for Regulatory Compliance. Prepares and conducts DMSI Andover Management Reviews. Also responsible for providing periodic reporting on a local and global level.
Ensures and drives DMSI Andover Audit Program. Supports audits and reviews the corrective actions regularly. Directs internal audits as part of the yearly audit program. Initiates product and process CAPAs when necessary. Monitors and reviews CAPA implementation and closures. Initiate product holds and ships when necessary. Develops, deploys and maintains quality management tools and methods.
Serves a member of the Andover Management Team, provides information to management that could impact QRA compliance and also promotes awareness of customer requirements and feedback to the management team.
Responsible for implementation of Integrated Management System within the DMSI Andover. Ensure effective Quality System implementation within the CFTs and Product Steering Boards. Educates responsible organization in all commercial and quality/process relevant topics. Promotes awareness to customer requirements, monitors quality performance and communicates customer quality issues and resolution thereof. Supports Managers in implementing modified processes.
Assures product quality by involvement in the development process. Assigns and manages Quality Engineering resources to support CFTs and Product Steering Boards. Assures effective Quality System compliance within each CFT, Product Steering Board and Product Quality Board.
Supports implementing, maintaining, and developing an effective Environmental, Health and Safety system.
Drives an analytical approach to problem solving utilizing the recognized techniques (e.g. Six Sigma + Lean, 8D, etc.)
Call Competent Boards and initiate recalls / special actions to ensure device safety.
Performs other duties as needed and assigned.
Internal code #LI-MC1 *mon*
Who you are
• Bachelor's Degree in a scientific discipline, life sciences, biomedical or other engineering science
• Master's or a PhD (desired)
• Further education in Quality and Environmental (knowledge of current ISO 9001, ISO 13485, ISO 14001)
• Further education in CMDR SOR/98-282, MDD 93/42/EEC and MDR 2017/745, 21 CFR Part 820, where applicable
• Formal Six Sigma qualification preferred
• Minimum of 10 years' experience in either a quality or regulatory role in the medical or safety device industry with at least 5 years in a management role
• Ability to develop, implement and manage an integrated QMS; to lead multi-level and multi-discipline work teams to develop, implement and manage processes/business systems
• Prefer experience in managing both quality and regulatory
• Strong influencing skills at all levels; to lead the decision-making process with executive management, peers and subordinates
• Sound people management and change management experience
• Strong interpersonal and communication skills and the ability to persuade and influence others at all levels within the company
• Capacity for analytical thought
• Proven track record in applicable disciplines of ISO 9001, ISO 13485, US FDA and MDD compliant Quality Management and ISO 14001 Environmental Management systems and demonstrated success in developing a proactive organization in a compliant environment
• Intercultural awareness
Domestic & International travel will be necessary (up to 10-15% of the time)