Quality Engineer - Consumables

Quality Engineer - Consumables

Job Title: Quality Engineer - Consumables
Contract Type: Permanent
Location: Birmingham, West Midlands
Salary: £28000 - £33000 per annum
Reference: HQ00055129_1491556575
Contact Name: Rachel Radford
Contact Email:
Job Published: April 07, 2017 10:16

Job Description

My client, a Medical Devices company, are seeking a Quality Engineer to join their facility based just outside of Birmingham.

The primary function of this role is to be the primary Quality contact of the Company for any outsourced suppliers who are engaged in all aspects of the manufacture of the machinery.

Key Responsibilities:

  • Responsible for review and acceptance procedure of protocols and reports into the company's document control system.
  • Responsible for QA review of Specifications and Technical drawings required by the supply chain for manufacture of the machinery.
  • Raising problem reports, Non Conformity reports, Corrective Action and Preventative Actions to address product quality concerns and/or QMS concerns.
  • Lead problem resolution sessions i.e. "8D", "5Y" to determine root cause(s) and to assess effectiveness of solutions

Additional responsibilities include:

  • Primary point of contact for all Quality Assurance activities relating to the manufacture of the consumable items associated with the machinery.
  • All activities generally undertaken by a QA dept. operating within medical device manufacturing, including but not limited to;
    • Auditing
    • New supplier approval process
    • Supplier corrective action requests
    • Complaints
    • Change management
    • Analysis, trending and reporting of data
    • Capability studies
  • Development of Quality specialism associated with consumables manufacturing i.e.
    • Sterilisation
    • Material characterisation

Key Requirements

  • Educated to degree level, with a related Bachelors degree in an Engineering or Science discipline
  • Prior experience of internal and external auditing, ideally within a medical devices environment
  • Transferable IT skills including eQMS
  • Willingness and flexibility to attend supplier sites, possibly for extended periods (UK & international)
  • Experience in medical device process verification and validation, such as:
    • Injection moulding
    • PCBA
    • Crimping
    • ESD control
    • Packaging
    • Sterilisation
    • Material characterisation
    • Control of clean rooms for manufacture.

If you are interested in this position and you feel like your skills are a good match, please apply today!