Farm, a Flex company with over 50 years of experience in providing award-winning development services for medical, life sciences, and consumer healthcare sectors, is seeking ain
Hollis, NH.
The
What a typical day looks like:
- Support product development as an embedded program team member working alongside program managers, researchers, human factors engineers, designers, mechanical engineers, electrical engineers and process engineers.
- Facilitate selection of suppliers to support late-stage development and clinical builds.
- Qualify suppliers via capability questionnaires, risk assessment, supplier file creation/management and remote or on-site audits.
- Represent program team supplier quality requirements during collaboration with procurement and supply chain resources.
- Develop program supplier and incoming inspection plans for late-stage development and clinical builds based on input from program managers, engineers, suppliers and customers.
- Plan and support test method and process validation activities completed by suppliers.
- Complete incoming inspection and management of materials for late-stage development and clinical builds.
- Manage site non-conforming material review process.
- Lead supplier-related corrective action and preventive action resolution.
- Manage site quality management system approved supplier list, supplier files and supplier performance metrics.
- Establish, evaluate, qualify, encourage use of and continuous improvement to supplier management processes, procedures and standard tools used by program teams.
- Participate in internal, customer and notified body audits of the quality management system.
- Interacts with customers, suppliers and external auditors to develop close working relationships.
- Participates in customer strategy meetings and discussions regarding the development of program quality requirements and plans.
- Participates in the technical review process on development programs.
The experience we’re looking to add to our team,
- Bachelor’s degree in engineering, science, or equivalent technical discipline
- 4+ years of supplier quality experience
- Analytical thinking, plus verbal and technical writing skills
- Demonstrated team collaboration experience
- Previous medical device industry experience/ ISO13485 (prefer)