Manufacturing Quality Engineer (Contract) - a Medical Devices company located in MN

Responsibilities

Develop, implement, and continuously improve manufacturing processes to enhance yield, reduce costs, and boost productivity.
Represent Process Engineering in R&D and Project Team meetings, offering technical expertise in technology transfers, analytical method development, validation, and process scale-up.
Conduct or manage process validations, including IQ/OQ, OQ, and PQ.
Troubleshoot production line issues related to yield, quality, and throughput.
Lead the scale-up processes from development to full-scale manufacturing.
Support the evaluation of NCMR, CAPA, SCAR, Failure Investigation, and Deviation requests from Contract Manufacturers/Suppliers.
Create and update manufacturing instructions, routings, bills of materials, and SOPs.

Qualifications

Minimum of 5+ years of experience in medical device manufacturing.
Experience with Design Transfer and Process Validations at external suppliers (CMO).
Proficiency in writing and executing associated validations.
Strong analytical and problem-solving skills (DOE, SPC, Six Sigma).
Knowledge of Class II/Class III medical device manufacturing and related quality system regulations.
Proven ability to consistently meet proposed timelines, utilizing project planning and project management skills effectively.
Excellent oral and written communication skills; ability to communicate with both technical and non-technical audiences.
Ability to effectively provide direction and support to external partners/suppliers.
Preferred experience with electromechanical assemblies.
Preferred experience with Design for Manufacturing.
Preferred experience in fixture development.
Preferred experience in the early stages of product development.

Education

Bachelor's degree in Biomedical, Manufacturing, Mechanical Engineering, or a related life sciences discipline.
Six Sigma Certification is a PLUS

a Medical Devices company located in MN

06/01/2024

Minneapolis,MN