Change Control Engineer

Kelly Services currently has an opportunity for a Change Control Engineer with a global medical equipment and technology company, located in Kalamazoo, MI

Job Title: Change Control Engineer, Instruments Division

Duration: 12 Months

Pay Range: $43 - $55/hour DOE

Summary

 This role will be supporting our client and a project to integrate acquired medical device products into our clients.

• Responsible for initiating, validating, and verifying the integration of acquired medical devices DHFs (design history files) into the client’s QMS (quality managmenet system).
• Due to market driven requirements, there will be changes to the product during this integration.
• Changes will at least include modify labeling, IFUs, and part markings.
• May be responsible for other DHF document drafts and management of RoHS or other restricted substances in product design.
• Responsible for ensuring the complete DHF and related PLM change requests are implemented in an organized and structured manner.
• Responsible for owning change requests to update labeling for compliance to applicable market requirements.
• Will support change notices, change tasks for updating labels, IFUs, and product markings.
• Develop DHF tangibles for review by the team.
• Coordinate with SMEs and approvers.

Requirements:

• 1-2 years' experience in medical device or similar field desired.
• Experienced with Windchill
• Bachelor degree in engineering field
• Candidates should have experience running cross-functional projects and technical writing

Top 3 Must-Haves:

1.

Experience with Windchill

2.

Attention to detail

3.

Good communication

Top 3 Nice-To-Haves:

1.

Ability to work independently with little direction

2.

Medical device experience

3.

Project management

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch.

Applicants must be legally permitted to work in the United States.

Please apply online or contact luisa.

ruthner@kellyservices.

com for immediate consideration

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hire placement with our clients, apply with Kelly to explore opportunities that suit your specific .

professional interests.

About

Kelly Services®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners.

Revenue in 2017 was $5.

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