Quality Design Engineer, Medical Devices

Job Title: Quality Design Engineer, Medical Devices
Contract Type: Permanent
Location: Crewe, Cheshire
Salary: Negotiable
Reference: J902075_1565712655
Contact Name: Tom Hammond
Contact Email:
Job Published: August 13, 2019 17:10

Job Description

Design Quality Engineer, Medical Devices

Location: Crewe

Salary: Competitive, plus additional benefits: Up to 7% bonus, life insurance, pension etc

Type: Permanent

Our Client, an established Medical Devices manufacturer are looking to recruit for an experienced Design Engineer to work at their modern R&D facility located in Cheshire. The successful Candidate will play a key part in the growth of the design and development team. This is a new role for this company and therefore there are no restrictions in terms of progression. This is an excellent opportunity for somebody to work in a hybrid -quality and design 360 role.

The Role:

To review, identify and support the remediation of design history files relative to the European Medical Device Regulations (MDR), ensuring products maintain quality standards and comply with regulatory/compliance standards.

  • Review of all R&D/Quality documentation (e.g. Design History Files, Design Control documents, Verification/Validation documentation, Risk Management files) in line with the General Safety and Performance Requirements specified within the MDR legislation.
  • Ensure that all product testing data is remediated or developed to MDR standards. Generate/approve/manage design verifications, design validations, sterilization validations, process validations, supplier qualifications, test methods, capability studies, and risk management documentation.
  • Update existing processes for maintenance/creation of design history files and other supporting documentation. In line with MDR requirements.
  • Prepare Design History files and other required supporting documentation in line with MDR regulatory submission timelines.
  • Any other reasonable duties as directed by the line manager.

The Person:

  • Will hold a Degree in a relevant Scientific/ Engineering discipline
  • Will have a strong understanding of 13485 Medical Devices standards
  • Design History File experience
  • Understanding the impact of regulatory requirements (eg. GMP's, ISO 13485, ISO 14971, MDD and MDR)
  • Must be able to provide and implement solutions
  • Ability to plan and schedule multiple projects and tasks

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