Quality Engineer/Risk Management

West Valley City, UT 84119

Posted: 09/16/2019 Employment Type: Contract Industry: Engineering Job Number: 80361
Our Client in Salt Lake City is looking for a Quality Engineer - Risk Assessment / Management (Contract) to assist the Quality team. This contract position will be for approximately 3-6 months. Our Client designs, manufactures, and distributes industry-leading enteral feeding and infusion pumps.

This role will be responsible for assessing the Risk Assessment / Management program for the site. This includes developing a formalized risk assessment / risk management program; including leading brain storming sessions, developing and updating FMEA and other risk related documents and procedures.
This position is responsible for leading cross functional meetings, developing meeting minutes, developing risk assessment tools, implementing a formalized risk assessment / risk management program.

The individual must be able to lead discussions and brain storming activities. The individual must be able to have high level technical discussions and be able to drill down to root cause and specific related issues.

Determination of quantitative or qualitative value of risk related to a process development, technical transfer activities, product characterization, and other concrete situations as well as recognizing possible risks, hazards, triggers, etc.
Job functions would include:

· Generation of risk assessment template

· Holding and orchestrating risk assessment meetings with cross functional teams

· Gathering input, rationalizing possible events, and discussing possible outcomes

· Works well individually and as a group

· Strong skill set with Microsoft Office

· Generate quantitative risk assessments

· Generated Failure Mode and Effect Analysis

· Generate reports with conclusions, discussions and recommendations
Experience: Minimum of three (3) years relevant experience performing risk assessments / risk evaluations within a device / diagnostic, pharmaceutical, or biotech environment.

· Education: Bachelor’s degree in Engineering, Life Sciences or related discipline (Engineering, Chemical Engineering, Chemistry, Biology, etc.)

· Familiarity with current industry practices and guidelines including those required / outlined by the FDA, ISO, EU, etc.



Apply Online

Send an email reminder to:

Share This Job:

Related Jobs: