Staff Product Transfer Quality Engineer

Reposted 15 Days Ago
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Skawina, Krakowski, Małopolskie, POL
In-Office
Mid level
Healthtech
The Role
The Staff Quality Product Transfer Engineer ensures successful product transfers by providing regulatory guidance, approving documentation, identifying quality gaps, and driving continuous improvement initiatives.
Summary Generated by Built In
Work Flexibility: Hybrid

We are hiring a Staff Quality Product Transfer Engineer to join our high performing team in a temporary role. There is excellent room for career progression & development for the right candidate.

This is a great opportunity for an experienced Quality Engineer to join our team and make a difference to our customer's lives every single day!

You will play a key role as part of a Global Team in supporting product transfers.

Responsibilities:

  • Supporting our transfers globally 

  • Having knowledge of and ability to provide interpretation and guidance on Regulations, Corporate and local site procedures as they relate to quality activities such as Control Plans, FMEA, MSAs, Validations and Qualifications.  

  • Reviewing and approving of Validation/Qualification Documentation.

  • Point of contact for quality for product transfers at Scoping, Planning and Execution phases 

  • Enable successful completion of product transfer to achieve its quality, cost and time requirements

  • Be able to identify PT quality risks/gaps and provide solutions to correct

  • Supports Product Transfer Process training where required

  • Provides feedback to Lessons Learned for each completed product transfer

  • Drive Continuous Improvement of the Product Transfer Process

Minimum requirements:

  • 4 years experience in Quality function, at least 1 year in medical device industry or similar regulated industry

  • University degree in Engineering, Medical Technology, or similar field of study

  • Process qualification and validation experience

  • Excellent communication skills and attention to detail.

  • Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.

Salary information will be provided during the recruitment process.

Please note this is a 24 months fixed-term contract.

Travel Percentage: 10%

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The Company
HQ: Irvine, CA
956 Employees

What We Do

Inari Medical, Inc. is a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases.

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