RTI Surgical Quality Assurance Engineer 2 in Marquette, Michigan

Position Summary:

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.

Responsibilities:

  • 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

Core Competencies:

  • Technical Knowledge

  • Quality Focus

  • Process Improvement & Innovation

  • Critical Thinking and Problem Solving

  • Results Oriented

  • Customer Focus

Education/Experience Required:

  • 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

Physical Requirements:

Light work: Physically handle objects up to 20 lbs. occasionally.

Work Environment:

Office Setting - Open layout with assigned work station or office