Quality Engineer (Medical Devices)

Location
Hampshire
Salary
40,000 - 60,000
Posted
16 Nov 2018
Closes
16 Dec 2018
Ref
JL16/11
Discipline
Quality, QA / QC
Contract Type
Permanent

I am currently working with a Medical Device and IVD Company based in Hampshire who are looking for a QARA Specialist to join their team as the company expands.

The salary will be between £40,000 and £45,000 depending on experience.

The QARA Specialist will be responsible for:

  • The upkeep and improvement of the Company’s quality systems and processes so that the Company meets Quality and Regulatory compliance.
  • To maintain the Quality Policy for the Group for the benefit of its customers, suppliers and employees.
  • To make recommendations for corrective action necessary to ensure conformity with quality legislation and specifications

Main duties and responsibilities 

  • The upkeep and further improvement of the Quality Systems and processes to ensure optimum compliance with relevant corporate and regulatory policies.
  • Support the Sr QA/RA Manager in maintaining a QMS that meets the applicable regulatory and company requirements including ISO 13485/9001/EC certification.
  • Assist in the creation of standard operating procedures and policy guidelines
  • Consulting company personnel in achieving and maintaining regulatory conformity as a prerequisite to worldwide market access of IVD products
  • Supporting the Sr QA/RA Manager with post-market regulatory compliance / surveillance activities for EU and International product approvals.
  • Assist with customer complaints
  • Assist with regulatory issues such as recalls or field safety corrective actions and advisory notices
  • Perform internal audits as required
  • Perform other duties as required or assigned by the Sr QA/RA Manager

Qualifications and experience required

  • Previous experience in successfully managing design projects for complex IVD devices
  • Ideally educated with a bachelor’s degree or HNC in a relevant scientific discipline
  • Strong regulatory background within the IVD industry is essential
  • Experience with ISO 13485, ISO 9001 and EC certification 
  • Experience in international medical device regulatory submission/approval preferred.
  • Auditing skills - Internal Auditor to ISO 13485/9001 is desirable
  • Knowledge of GHTF STED, and IVD CTS documentation requirements
  • Strong team player providing support, guidance and expertise in achieving regulatory compliance and customer satisfaction by educating, analysing and facilitating improvements through interaction with both internal and external customers
  • Root cause analysis techniques, FMEA and risk analysis techniques.
  • Knowledge of Design control, Risk Management, Product Development processes and Batch Release.
  • Experience with New Product Introduction and R&D team to lead regulatory input in R&D project.

If this is something that either you or someone you know, has the required experience and is interested, then please do apply online with a copy of your most recent CV and give Jack Lundgren a call on 0207 812 7700.

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