Quality Engineer



Advert ID



Maple Grove

Job Type




Salary Range


No. of Openings


Branch Information

Minnesota Engineering - (USA) 3600 Minnesota Drive Suite 850 MN Edina , MN 55435 Phone : 612-630-1200



Job Description

Quality Engineer II or Quality Engineer III | Maple Grove, MN | Contract to hire | $40-$60/HR | Medical Device Industry

A medical device client we're partnering with is seeking a Quality Engineer II or Quality Engineer III to help on a main project that's focused around closing CAPAs. Potential to convert to a full time employee after the 6 month contract duration.

* Responsible for drafting and/or updating Quality Procedures for Quality Operations functions.

* Responsible for Non-Conforming Material Reports (NCMR) including root cause investigation, risk assessment, historical record review, disposition strategy, correction activities.

* Responsible for Complaints Reviews/Manufacturing Analysis including event assessment, root cause investigation, risk assessment, historical record review, impact/action escalation.

* Responsible for Corrective Action Preventive (CAPA); including root cause investigation, scoping/bracketing, resolution planning, implementation, and verification of effectiveness.

* Support/participate in regulatory agency and customer quality audits.

* Working knowledge of concepts of probability and statistics as well as aide in updating/establishing SPC and Gage R&R studies.

* Work with suppliers of both raw materials and components to improve product quality and/or resolve quality issues.

* Write and or assist in development of protocols, technical investigation plans, engineering reports, and related procedures which ensure statistical validity, adequacy, and compliance to regulatory and corporate requirements.

Manufacturing/Operations Responsibilities

* Act as a Quality lead to oversee day-to-day Manufacturing activities

* Responsible for driving continual process improvements in responsible areas of the business. Drive quality and manufacturing improvements to assure that processes are in a state of control.

* Responsible for Manufacturing/Production Line Support - partnering with operations team members to achieve value stream goals and objectives.

* Provide input and expertise to manufacturing on sample sizes and statistical methods.


BS or MS: Engineering Field

2+ years as a Quality Engineer within the medical device industry (ISO 13485)

Good experience closing CAPAs & overall Quality Engineering experience

**Open for Contract to hire