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Sustaining Systems Design Quality Engineer II
Sustaining Systems Design Quality Engineer IIZipRecruiter • Osseo, MN, US
Sustaining Systems Design Quality Engineer II

Sustaining Systems Design Quality Engineer II

ZipRecruiter • Osseo, MN, US
19 hours ago
Job type
  • Full-time
Job description

Overview

POSITION : Sustaining Systems Design Quality Engineer II

FULLTIME : 12-Month Assignment (Possible temp to hire for right individual and if budget allows.)

LOCATION : Maple Grove, MN (Hybrid)

SCHEDULE : 8AM-4 : 30PM

PAY RANGE : $35-42 / HR

Exact compensation may vary based on skills, experience, and location. Base pay information is based on market location.

Job Description

The Design Quality Engineer II will support application of design controls to projects focusing on design changes, material continuity, regulatory and standards compliance, corrective and preventive actions, and improvements for manufacturability and cost reduction. This individual will work with a high performance cross-functional team to ensure safety, quality, and compliance of products.

Responsibilities

  • Ownership of design change projects including scoping, assessment, and implementation.
  • Develop, update, and maintain Design History File and Design Input / Output documentation.
  • Update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA.
  • Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements.
  • Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Quality Systems Duties and Responsibilities

Build quality into all aspects of work by maintaining compliance to all quality requirements.

Qualifications

  • 3-5 years with BS. Degree must be clearly stated on resume.
  • Bachelor's degree in mechanical, electrical, or biomedical engineering.
  • Experience with design control, risk management, and medical device standards compliance.
  • Experience with corrective and preventive action.
  • Adaptable and effective collaborator in a team environment and in self-directed work.
  • Strong communication skills (verbal & written).
  • Working Conditions

  • Occasional exposure to loud sounds and distracting noise levels from office equipment.
  • The ability to lift up to 30 lbs.
  • Use of computers and technology.
  • Canon Recruiting is committed to a diverse and inclusive workplace. Canon Recruiting is an equal opportunity employer and does not discriminate on the basis of protected status or other legally protected characteristics. We will consider for employment qualified applicants with arrest and conviction records. Our range of benefits may include health care and 401(k) savings plans. For individuals with disabilities who would like to request an accommodation, please email hr@canonrecruiting.com.

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    Quality Engineer Ii • Osseo, MN, US

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