Medical Device Quality Manufacturing Engineer

Minneapolis, MN

Job ID: 122560 Industry: Med
Medical Device  Quality Manufacturing Engineer


Our client is a large medical device supplier. They distribute a number of class 2 and 3 medical implants. They are in need of a Quality Manufacturing consultant to come in and take manufacturing ownership of commercialized product and assist Quality and Sourcing with routine product maintenance.

Principle Duties and Responsibilities:

The client is in need of a Quality Manufacturing Engineer. This person will help Complete verification and validation master plans for supplier qualification and / or certification. Lead validating specialized processes (cleaning, endotoxin, chemical characterization, porous and plasma coating, additive manufacturing, injection molding, etc.) Lead critical supplier process control and process performance validation activities (IQ, OQ, PQ, PPQ). Interface with suppliers and QE to coordinate or support root cause analysis and corrective actions. Lead or support process FMEA, risk mitigation and control activities

This person should also have experience with Orthopedic manufacturing process development (Master routes, BOM’ s,  defining inspection criteria, cleaning, packaging, labeling) and supplier control plans. It would be ideal if they have experience with manufacturing quality tools (process capability, GR&R, statistics, process FMEA, SPC / process controls planning).  Responsible for sustaining manufacturing BOM’ s, item cards,  routings, engineering change review, and process specifications.  The ideal person should be 75% manufacturing and 25% project management, They will be leading a small cross functional team. 

Required skills:

·      5 to 7 years of hands on process development experience of manufacturing, cleaning, inspection, packaging, and labeling processes

·      Minimum of 3 years experience in medical device manufacturing and quality systems

·      Knowledge and experience working with ISO 14971, 13485, 14971, 10993 and 21CFR Part 820 regulations

·      Demonstrated use of quality tools (Statistics, Lean, Six Sigma, DOE, etc)

Job Type: Contract  

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