Role details

Quality Engineer

Chelmsford   •   £35,000 - £45,000   •  Permanent

Bullet points

  • Experience needed within medical devices
  • Must have auditing experience (Internal/External)

About Our Client

My client are a specialist medical device manufacturing business who are experiencing a great deal of growth within their business. Based in Chelmsford in Essex - they supply globally and have recently secured a number of contracts. This role will sit within their Technical department reporting into the QA/RA Manager.

Job Description

The key responsibilities for the Quality Engineer will be:

  • Develop and maintain quality / inspection documents including but not limited to product specification, inspection criteria and test methods

  • Take ownership and improvement initiatives of CAPA process

  • Lead and support CAR owners in the investigation & root cause analysis

  • Lead and support product failure investigation arising from customer complaints, product returns or quality issues

  • Participate with technical and production team in validation activities (product/process)

  • Participate in BOMs meetings and material qualification

  • Support the quality control team in the product testing/verification activities as required

  • Conduct supplier quality audits

  • Such added duties as required by the department

The Successful Applicant

The ideal candidate for the Quality Engineer role will have the following background:

  • 3+ years' experience in manufacturing environment within a regulated industry (medical device / drug)

  • Working knowledge of international/harmonised standards, such as, ISO 13485, ISO 14971, EN 62366

  • Knowledge of Medical Device Regulations (EU/Global) would be advantage but not essential

  • Relevant scientific / engineering degree in mechanical/industrial or biomedical (desirable)

  • Experience in conducting and generating validation protocol & report

  • Experience in process control improvement projects

  • Experience in QMS or supplier audits

  • Proficient in quality/process improvement tools and techniques, such as, SPC, DOE, FMEA, 8D, 5Ws/Ishikawa

  • Good communication skills both written and verbal

  • Good interpersonal skills as constant interaction with external / internal parties is expected

  • Highly organised, Change management

What's on Offer

The successful candidate for this role will be offered between £35,000 - £45,000 per annum (dependant on experience) + a competitive benefits package.

Apply for this job

Click the Apply or LinkedIn button below or contact Martin Ofosu on +44 207 269 2369 quoting job reference 13763121
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