Quality and Regulatory Engineer

Job Description

Our client is looking for a Regulatory Engineer who can mark CE custom-made devices to the Medical Devices Regulation and managing these regulations. This includes creating and maintaining the relevant technical files and updating the product user and technical instructions for use. This role will maintain the upkeep of ISO9001…

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Our client is looking for a Regulatory Engineer who can mark CE custom-made devices to the Medical Devices Regulation and managing these regulations. This includes creating and maintaining the relevant technical files and updating the product user and technical instructions for use. This role will maintain the upkeep of ISO9001 and ISO14001 manuals in conjunction with the ISO consultant and keep the Health and Safety policies up to date in conjunction with changes within manufacturing processes.

Key Responsibilities and tasks:

  • Create technical files for all products in line with the MDR
  • Produce all requirements to fulfil ISO 9001
  • Produce all requirements to fulfil ISO 14001
  • Ensure all NCR and quality assurance forms are processed and recorded correctly
  • Produce and update work instructions for all products they manufacture
  • Communicate daily both externally with suppliers and internally with all levels within the company using appropriate communication skills and methods to deliver the message effectively.
  • Put in place quality checks for the standard of the Technician’s work ensuring it complies with the company’s processes, CE standards and ISO 9001.
  • Initiate, develop and implement any process changes that would optimise efficiency within the Workshop.

Benefits:

  • Possibility of flexible start and finish times
  • Life insurance
  • Pension scheme
  • Free Parking

Job Description

Our client is looking for a Regulatory Engineer who can mark CE custom-made devices to the Medical Devices Regulation and managing these regulations. This includes creating and maintaining the relevant technical files and updating the product user and technical instructions for use. This role will maintain the upkeep of ISO9001 and ISO14001 manuals in conjunction with the ISO consultant and keep the Health and Safety policies up to date in conjunction with changes within manufacturing processes.

Key Responsibilities and tasks:

  • Create technical files for all products in line with the MDR
  • Produce all requirements to fulfil ISO 9001
  • Produce all requirements to fulfil ISO 14001
  • Ensure all NCR and quality assurance forms are processed and recorded correctly
  • Produce and update work instructions for all products they manufacture
  • Communicate daily both externally with suppliers and internally with all levels within the company using appropriate communication skills and methods to deliver the message effectively.
  • Put in place quality checks for the standard of the Technician’s work ensuring it complies with the company’s processes, CE standards and ISO 9001.
  • Initiate, develop and implement any process changes that would optimise efficiency within the Workshop.

Benefits:

  • Possibility of flexible start and finish times
  • Life insurance
  • Pension scheme
  • Free Parking

Job Summary

Location: Southampton
Salary: £37000.00 - £37000.00 Per Annum
Contract Type: Permanent
Sector: Engineering
Division: Engineering
Date: 22nd February 2024

Apply now

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Key Contacts

Danielle Hider

Danielle Hider

Recruitment Consultant

Email: Click here
Phone: 023 9232 4666

Clare Sayers

Clare Sayers

Divisional Manager

Email: Click here
Phone: 023 9232 4666

Daimion Eastley

Daimion Eastley

Director

Email: Click here
Phone: 023 9232 4666

Apply now

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Job Summary

Location: Southampton
Salary: £37000.00 - £37000.00 Per Annum
Contract Type: Permanent
Sector: Engineering
Division: Engineering
22nd February 2024

Apply now

Share this job: