The Manager, Quality Systems will be a strong partner to the Global Quality and Regulatory function, as well as across the Diagnostics Information Solutions (DIS) Business Area.
- Manages and coordinates Quality Systems activities. Assures local and partner Quality Management Systems (QMS) compliance with FDA Quality System Regulation (QSR) and International Standards Organization (ISO) regulations. Provides direction to local and partner management to establish, implement, and maintain policies and procedures designed to ensure compliance with all necessary and appropriate quality standards.
- Interacts across organizations, levels, and groups to establish short term objectives to align with company vision and accomplish organizational goals.
- Partners with the DIS organization to ensure strategic Quality Systems initiatives are implemented, including integration, harmonization, continuous improvement, and Quality Systems technology advancements.
- Performs administrative functions for Quality staff including performance management, goals and objective setting, and personal development planning. Assures short term training needs for staff are addressed, and longer term individual and organizational development needs are identified, planned, and implemented. Manages external resources, including consultants.
- Leads cross-functional project teams, acts as organizational matrix manager, and makes near-term decisions that may impact local area and programs.
- Responsible for ensuring continuous process improvements and other Corrective and Preventive Action programs are executed to maintain compliance with Federal, State, and local regulations pertaining to QSR, ISO, and associated Regulatory agencies.
- Performs training to meet business requirements. Responsible for ensuring the local organization is trained on QSR, ISO, and other associated Regulatory requirements through the development and implementation of compliance education and training courses.
- Interfaces with Regulatory agencies and professional organizations to ensure the Quality Management System remains current and competitive.
- Interacts with local Information Management functions to evaluate, test, and implement programs or changes linked to Information Technology systems or data analytics. Applies business process knowledge to manage the design and improvement of quality processes to improve system utilization while maintaining compliance; presents new or upgraded system capabilities and drives knowledge to users.
- Provides input to the budget planning process and helps to identify opportunities to reduce costs and allocate resources efficiently. Works with Procurement on contract negotiations and/or supply/quality agreements.
- Expected to operate independently, holding him/herself accountable to proactively fulfill tasks and achieve results within assigned timelines. Works on complex problems requiring significant analysis and evaluation. Utilizes established precedents, policies, and expertise.
- Expected to understand strategic priorities developed by upper management and to respond to requests with appropriate urgency and with an organized approach.
- Bachelors’ degree in Biological Sciences, Quality Engineering or related field, or equivalent combination of education and work experience
- Master’s degree/PhD, or equivalent preferred
- 7+ years minimum (9+ preferred) of relevant medical device industry experience, including experience focused on quality systems, regulatory affairs/compliance, project management, controlled documentation, quality data analytics, or change control.
- Thorough working knowledge of relevant international ISO Standards (ISO 13485, 14971) and regulations, especially MDD/MDR and 21 CFR - part 820.
- Experience in Agile Software Development and Quality Management Systems adapted to enable the application of Agile in medical device software development.
- Experience in establishing a Quality Management System to comply with MDD/MDR requirements.
- Enthusiasm for the role that Quality and Regulatory (Q&R) can play in enabling the development and manufacture of products for our patients.
- Drive to engage positively with Q&R/Business teams and make impactful contributions in a multi-cultural/national environment.
- Track record of providing sound Q&R judgment/ideas, effective people management, and business partnering.
- Strong leadership/interpersonal/integrating/problem-solving skills and demonstrated ability to collaborate effectively across a variety of workgroups in demanding/changing situations (medical, scientific, and manufacturing).
- Strong communication skills, with ability to get points across clearly and simply.
- Scrum master certification is a plus.