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QA Officer - Medical Devices

Job Title: QA Officer - Medical Devices
Contract Type: Permanent
Location: Liverpool, Merseyside
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: J909456_1647450213
Contact Name: Johnathan Miller
Contact Email: Johnathan.miller@russell-taylor.co.uk
Job Published: March 16, 2022 17:03

Job Description

QA / RA Officer

Based in Liverpool

Permanent

Monday - Friday 8:30am - 4.30pm

Competitive salary - please get in touch for details

Parking onsite, private medical, life assurance, company pension, attendance bonus

Our Client, an established Medical Devices company / IVD are looking to recruit for 2 additional experienced QA Officers to work at their modern R&D facility based on the outskirts of Liverpool. The roles also includes additional duties across Regulatory Affairs in relation to Medical Device regulations.

Duties:

  • The successful QA / RA Officer will work closely with Quality Assurance Manager and assist in ensuring that all aspects of Clients Group QMS remain effective.
  • Assist in maintaining compliance with all applicable Quality standards regulatory and statutory requirements necessary to the continued business activities of the Client.
  • Assist in ensuring that all documents and information relating to customer regulatory requirements are generated and available as required.
  • Investigate and rapidly resolve all complaints relating to Clients products and services, ensuring that the necessary CAPA measures are identified, documented, logged and actioned in a timely manner, in accordance with the Client Group Quality Management System (QMS) requirements and appropriate regulatory requirements.
  • Work with R&D staff in the compilation / storage and accessibility of regulatory required product Technical Files.
  • Provide support and advice to Company departments in regulatory matters, as required.
  • Assist with promoting the principles of regulatory requirements to all staff in conjunction with the QA&QARA Managers, under the overall direction of Top Management (Client Company Directors).
  • Work alongside and under the direction of the QA/QARA Managers in any of the following activities as required; identifying and ensuring compliance with all applicable standards, regulations and directives, relating to IVD medical device products, QMS, and other statutory legislation e.g. health and safety at work and environmental management; Ensuring that Client's products are designed, manufactured, marketed, sold and shipped in compliance with current IVD medical device regulatory requirements and other applicable regulations and standards.
  • Ensure that Clients products are registered in accordance with all relevant national requirements for each country.
  • Assist the QARA team in managing product vigilance issues, including field safety notices, customer advisory notices and liaison with National Competent Authorities as required.
  • Work with QA/QARA Managers, as required, on any QARA related activities, such as Internal Audits, Document Control, Non-Conformance, Supplier Approval etc.
  • Work with Research and Development, and Quality Control staff in the compilation/storage and accessibility of product technical documentation in accordance with applicable regulatory requirements.
  • Working as part of the QARA Team to provide support and advice to Company departments in regulatory and quality assurance matters, as required. This includes equipment calibration and monitoring: process verification and validation; document training; Investigation and rapid resolution of complaints relating to Clients Group products; recall and vigilance reporting and liaison with National Competent Authorities as required; ensuring that necessary improvements and corrective and preventative (CAPA) measures are identified and implemented; Internal audit scheduling.

Qualification and Experience:

  • Minimum educated to Degree level in a Life Science (Biomedical, Microbiology, Biotechnology, etc) subject.
  • A solid understanding of ISO 134845, 9001, 17025 standards and working to these QMS.
  • Will have worked in the IVD/ Diagnostics sector.
  • The ideal Candidate will have previous regulatory experience.
  • Experience in raising non conformances, CAPAs etc is desirable.
  • Strong report writing skills, and communicative skills required.
  • Will be IT proficient working across a range of software's and applications.

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