Quality Engineer

Job Description

Description :

Job Title : Quality Manufacturing Engineer

Work Location : Sturtevant WI

Duration : 6 + Months

Payrate : $40-$42

Job Description :

The Contract Manufacturing Organization (CMO) Quality Specialist position will ensure quality in the day to day activities of the manufacturing organizations of our electro mechanical devices. It will ensure products meets established quality standards throughout the manufacturing process. The position will also provide direct support to Quality Management / Quality Engineering personnel regarding operation of the department and Quality System. It will provide support to other departmental activities as directed.

What You Will Do

Quality and Manufacturing Operations Coordinate teams to solve manufacturing quality problems in a timely fashion. For example. Analyze scrap data and identity methods of reduction.

Review yield data and recommend process improvements to increase it.

Review process flow to identify sources of inefficiencies and methods to improve through put. Act as a liaison between quality and contract manufacturing departments. Initiate and / or support the development of protocols and final reports for manufacturing or other quality control projects. Support manufacturing needs by ensuring proper testing is in place for raw materials, finished goods, validation, in-process material and final products is completed accurately, timely and documented correctly.

Quality System Support Support other Quality System functions as assigned by Quality Management that are related to documentation review, equipment calibration, nonconformance review, Out of Specification (OOS), Corrective and Preventative Actions, product complaint investigations (if applicable), audits, and other tasks as directed.

Audit Support Participate with federal, state, and local regulatory officials during regulatory inspections. Support internal and vendor quality system audits.

Adherence to regulations Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of medical devices.

Other duties as assigned Provides support to Quality Management and Engineering personnel and perform other duties as assigned.

Minimum Requirements

Bachelor's Degree in Physical Science or Engineering or equivalent experience

2+ years Medical Device or Pharmaceutical Industry or similar experience.

2+ years In a Quality Role.

2+ years Working with electromechanical device manufacturing or contract manufacturing.

2+ years In Manufacturing Quality or Operations Role

Preferred Qualifications

Computer skills in Microsoft Word, Excel, PowerPoint, Visio; Adobe; and Quality System Management Software.