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in Oshkosh, WI

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Hours Full-time, Part-time
Location Oshkosh, Wisconsin

About this job

Location:

Duration: 7-months

Payrate: $46-52/hr.

RESPONSIBILITIES

 

  • Candidate must have FDA medical device Class 2 or Class 3 Risk Management and Design engineering experience.
  • This is a Quality Engineer role supporting Risk Management File documentation updates (FMEAs, Risk Management Plans, Risk Assessments, and associated procedures), change control creation and execution in a document and change management system (EtQ).
  • Primary responsibilities will include the writing and updating of Quality procedures and work instructions governing the Risk Management and Design activities.
  • This will require learning our change control process, opening and managing change package through to release.
  • This individual will also work with engineering teams to execute the Risk Management and Design activities to create Risk Management File deliverables.
  • The candidate must have experience working in Design Controls and Change Control systems for FDA regulated medical devices.
  • The role will be supporting Quality system improvement initiatives – remediation of quality system documentation, design documentation, DHFs, DTMs, RTMs, etc.
  • We need a team member with strong technical skills, excellent written English and oral communication skills and high attention to detail. Experience in ETQ as a quality system is preferred

 

Skillset for this role:

• Excellent written and oral English language skills

• Quality system documentation and change management experience

• Medical device (FDA Class II) Risk Management engineering development project support

• QMR presentation slide preparation

• CAPA Investigation and Effectiveness support

• Procedure, Work Instruction and quality system documentation

• Attention to details

Why Kelly?

As a Kelly employee, you’ll have access to premier perks, including:

  • Kelly-sponsored Affordable Care Act health care coverage available to eligible employees
  • Group insurance options
  • Service bonus plan
  • Holiday pay plan
  • Weekly electronic pay options
  • Online training campus that provides more than 3,000 free courses to help improve and develop skills
  • Outstanding online employee community Corporate discounts
  • Transportation Spending Accounts
  • Offered and coordinated by EnrollVB These plans are not sponsored by Kelly Services.

APPLY NOW !!!

 



Why Kelly®?

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we’re here every step of the way to find your dream engineering job.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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