RTI Surgical Quality Assurance Engineer 2 in Marquette, Michigan
This position is responsible for the quality engineering support in the development of medical implants & instruments. This will involve modeling and detailing implant/instrument inspection prints, delivering validation reports, and providing solutions to optimize the development process. The Engineer 2 will demonstrate good judgment in selecting engineering methods and techniques for obtaining solutions and networks with senior internal and external personnel in own area of expertise and resolve a wide range of issues in creative ways. This position will help RTI Surgical maximize the number of patients served while maintaining a high level of quality and safety.
Support risk management process during the development of products
Support design transfer process for newly developed products
Support on-boarding of new suppliers as needed for newly developed products
Responsible for developing appropriate test methods and inspection plans. Test methods shall be validated as necessary.
Responsible for interpretation and application of sampling plans and statistical techniques (e.g. SPC, DOE).
Provides support and appropriate review of process and design validation activities.
Support and Perform Measurement system analysis and Gage R&R’s
Completes / performs review of / provides leadership in nonconforming product/process evaluation, and CAPA’s.
Support and develop quality metrics
Responsible to ensure appropriate change control activities occur as supplied products/processes are modified and improved.
Directly supports RTI quality systems and process improvement initiatives.
Responsible for reviewing and approving SOPs, work instructions, material specifications, product specifications and associated engineering drawings.
Provides guidance and direction for product review activities and product audits.
Supports third party audits as necessary.
Responsible for establishing and promoting professional working relationships with both internal and external associates and customers, in development of quality plans, procedures, and test methods.
Other duties as assigned
Process Improvement & Innovation
Critical Thinking and Problem Solving
Bachelor of Science Degree in Biomedical, Mechanical Engineering, or Engineering Technology
5-8 years engineering experience(Bachelors)/3 years’ experience (Masters) designing and/or modifying products
Lean/Progressive Manufacturing and Quality disciplines. ASQ CQE preferred
Fundamental understanding of design controls, project management, and basic manufacturing practices/processes
Light work: Physically handle objects up to 20 lbs. occasionally.
Office Setting - Open layout with assigned work station or office