Quality Engineer, Medical Devices

Job Title: Quality Engineer, Medical Devices
Contract Type: Contract
Location: Keighley, West Yorkshire
Salary: Negotiable
Reference: J908290_1620727605
Contact Name: Tom Hammond
Contact Email:
Job Published: May 11, 2021 11:06

Job Description

Quality Engineer, Medical Devices

Location: North Yorkshire

Type: Fixed Term Contract for 18 months

Salary: Competitive DOE

Additional: Upto 5% bonus, Pension - EE 3%, ER 6% or EE 4%, ER 8%, 4x annual salary life assurance

Cont… BUPA private medical care, canteen, and gym onsite

Hours: Monday - Thursday (8.30 - 16:30), Friday (8:30 - 13:30)

Our Client, an established/global medical device company currently experiencing major growth; is looking to recruit for an experienced Quality Engineer who will work at their modern site in North Yorkshire.

This position reports into the Quality Engineering Manager

The Role:

  • Liaise with Relevant Departments on the completion of risk assessment, Work Instructions, Validations and FMEA's for both new product introductions and existing product line changes/process improvements.
  • Contribute to, review and/or develop and execute facility, software, process and equipment validations and risk management documents
  • Review change controls for process/design impact.
  • Knowledge of statistics to assist with validation developments and process improvements
  • Provide quality support to relevant departments with sampling plans, data processing or analysis for validation for new and existing product lines.
  • Assist in the analysis and resolution of problems that may reduce the efficient running of production lines.
  • Complete NC and CAPA investigation, processing and disposition.
  • Ensure continuous compliance for Product Manufacturing, Packaging and Labeling.
  • Perform Internal Audits/Supplier Audits.
  • Assist in the development, analysis and improvement of site Quality Metrics.
  • Lead/Support project activity in your area of responsibility
  • Will abide to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.
  • Actively contribute to the enhancement of compliance initiatives for areas of responsibility.
  • Will comply with all relevant training required and adhere to relevant associated documentation.
  • Follow strict adherence to the requirements of cGMP.
  • Liaise/support with suppliers to ensure drawings and specifications are clear, understood and fully compliant.

The Person:

  • Experience of working within a Quality environment within the Medical Devices / Pharma Industry.
  • Will have experience in CAPA, auditing, validation and risk management in a QA/ QE setting ideally (not QC/ Analytical Lab setting).
  • A Degree in Engineering or Science is beneficial as the role includes review of analytical data.
  • They will have the ability to perceive and drive forward improvement in the manufacturing areas in regards to Quality.

Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy h t t p s : / / w w w . r u s s e l l - t a y l o r . c o . u k / p r i v a c y - p o l i c y on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or the GDPR please contact us on h r @ r u s s e l l - t a y l o r . c o . u k

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