Quality Engineer II

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Apex Systems
Full Time

Job Description

Job#: 1253858

Job Description:

Apex Systems is currently seeking a Quality Engineer for one of our top Medical Device clients in Maple Grove, MN.

Please see below for details about this exciting growth opportunity, and email Lisa at asap to learn more!

Role: Quality Engineer

Location: Maple Grove, MN

Organization: Fortune 500 Medical Device company who prides themselves on culture, work-life balance, and overall well-being (winner of Forbes Best Employers for Diversity (2018 - 2020), Forbes World's Best Employers (2018, 2020) and Forbes Best Employers for Women (2018))

Length: Long-term renewable contract, potential for conversion

Compensation: $83,000-$104,000K range depending on experience, qualifications, certifications, etc.

Additional Details/Perks: As a Contractor with Apex, you'd have access to two additional training programs, healthcare benefits, 401K, employee stock purchase program, weekly pay, and other benefits. Training provides hundreds of courses, and certification bootcamps/credits for all major PMI certifications.

Job Description
  • Define the development of comprehensive specifications (hardware and/or software) for equipment/software from basic functionality to complex systems such as PLC's, Visual Basic applications, databases, SCADA applications, and systems with FDA defined electronic records and electronic signatures.
  • Provide project estimates independently.
  • Submit specification, protocol and report for approvals and documentation control via a Change Request.
  • Develop comprehensive software validations and/or equipment qualification protocols per the specification.
  • Execute software validation and/or qualification protocols & record results.
  • Document, communicate and follow-up on software/equipment issues.
  • Complete project deliverables per project schedule and monitor project schedule and scope changes to assure team can meet delivery requirements.
  • Create documents, links and Change Requests utilizing a Product Data Management system.

List required Education/Experience/Skills a candidate must have to successfully perform the above duties/tasks
  • Bachelor's Degree in Engineering or Scientist Discipline
  • 3-5 years direct experience
  • Experience in Medical Device compliance documentation
  • In depth knowledge of MS Office tools
  • Must have excellent organization, clear verbal and written skills
  • Hand on skills using navigating equipment user interfaces
  • High level attention to detail and ability to support multiple priorities at once
  • Must be team-oriented with people skills and positive can-do attitude in dealing with many customers, from various departments (Engineering, R&D, Manufacturing, Regulatory, etc.)

List Education/Experience/Skills that are not required, but helpful
  • Experience working in FDA-regulated industry
  • Performed in a quality role ensuring industry compliance
  • Practical knowledge of 21 CFR Part 11 (electronic records/electronic signature)

Quality Systems Duties and Responsibilities:

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

Please email Lisa at if you or anyone you know is interested in learning more about this Quality Engineer opening or exciting other job opportunities!!

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .

Company Information

Apex Systems is a world class technology services business that incorporates industry insights and experience to deliver solutions that fulfill our clients’ digital visions. We provide a continuum of service from workforce mobilization and modern enterprise solutions to digital innovation to drive better results and bring more value to our clients. Apex transforms our customers with modern enterprise solutions tailored to the industries we serve. Apex has a presence in over 70 markets across US, Canada and Mexico. Apex is a segment of ASGN Inc. (NYSE: ASGN)

Dice Id : apexsan
Position Id : BHJOB2374_1253858
Originally Posted : 2 months ago

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