LINQM is adding a Quality Engineer to the team.
Apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.
Responsible for defining supplier qualification requirements for OEM, Contract manufacturer and custom materials, including supplier and receiving inspection criteria and test method validation, defining and supporting implementation of part qualification activities at the suppliers.
Develop complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports. This also includes developing test methods working with suppliers and at receiving inspection.
Develop, update, and maintain technical content of risk management files
Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
-Understanding of standard manufacturing processes, assembly procedures, test and inspection requirements especially relevant to hardware assemblies
-Working knowledge and understanding of statistical techniques
-Previous experience working with lab/industrial/test equipment required
-Ability to read and interpret drawings, and navigate product documentation
-Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
-Strict attention to detail
-Ability to manage competing priorities in a fast-paced environment
-Knowledge and understanding of FDA and international regulatory standards for medical devices is preferred
Bachelor's Degree in Engineering or Scientific field with 2 Years of Experience OR Master's Degree in Engineering or Scientific field