Neutron Therapeutics, Inc. (Neutron) is headquartered in Danvers, MA, USA with an additional European office located in Helsinki, Finland. Neutron is committed to the design, development, and supply of high quality, safe, and effective medical devices.
Neutron Therapeutics is seeking a Quality Assurance Director professional to support our Danvers, Massachusetts location.
Neutron Therapeutics seeks a motivated, team player who will be responsible for ensuring internal compliance to the Neutron Quality Management System, and will ensure overall Quality Management System compliance with applicable regulatory requirements, including but not limited to 21 CFR 820 (Quality System Requirements), EU Medical Device Directive (MDD), EN ISO 13485:2016, EN 14971:2012.
Key Duties and Responsibilities:
- Manage all aspects of the Quality organization and the Neutron Quality System
- Provide organizational leadership for the Quality Management System
- Build the Quality organization as Neutron matures from an R&D-based start-up into a commercially operating company
- Provide direction to the organization, communicating department and company goals and objectives, ensuring employee competence and awareness, identifying training needs, and providing appropriate training
- Optimize the processes within the Quality organization and Quality System including linkages to other departments and business processes
- Collaborate with the management team to establish quality objectives in alignment with Neutron’s overall company objectives
- Present quality objectives and key performance indicators in management review meetings and other forums
- Directly manage any Quality Assurance staff
- The Director will be expected to be a “working manager.”
- Basic time management, organizational, and prioritization skills to successfully complete job duties and responsibilities in a timely manner
- Basic problem solving skills and ability to resolve problems in a timely manner
- Basic communication and presentation skills to properly communicate relevant information to peers
- Bachelor of Science in Engineering, Biological Sciences, or related field
- Advanced degree or MBA preferred
- 10 years or more of medical device industry experience, including 5 years of managerial experience or equivalent combination of education and relevant experience.
- Applied understanding of ISO 13485, and FDA regulations for medical devices
- Experience with ISO and FDA on-site audits with a successful track record
- Good understanding of 21CFR Part 11
- Demonstrated expertise on Process and Product Validation and Statistical Methods
- Demonstrated experience handling supplier quality issues
- Demonstrated ability to lead and work effectively in a cross-functional team environment
- Excellent verbal and written communication skills
- Experience with radiation emitting capital equipment preferred
- Works under general supervision, reports to CEO
- A certain degree of creativity and latitude is required
Neutron Therapeutics is an equal opportunity employer.