Quality Engineer

09 Jul 2024
06 Aug 2024
Contract Type
Full Time

Job Title: Quality Engineer

Industry: Medical Device Manufacturing

Location: Plymouth

Position Type: Permanent

About The Company

Join a pioneering team at a UK-based company specializing in advanced wound care and wound closure products. An organisation dedicated to developing and manufacturing world-leading solutions that enhance patient care. With a wealth of resources and specialized expertise, they offer a unique opportunity to be part of a team involved in every aspect of product design, development, and manufacture.

Job Description


Reporting to the Quality Manager you will be responsible for technical documentation, project management and co-ordination of projects with other departments.

This job will aid in the maintenance of compliance to relevant cGMP, FDA QSR 21 CFR 820, ISO13485 & European Medical Devices Directive MDD94/42/EEC.

Key Responsibilities

  • Deputy to the QM
  • Maintain and improve quality compliance.
  • Identify, manage, and implement continuous improvement initiatives.
  • Evaluate product & process risks in line with Medical Device Risk Management requirements.
  • Support New Product Introductions.
  • Handling & investigation of Customer complaints.
  • Timely resolution of identified non-conformances and implementation of effective corrective action.
  • Identification of potential areas of non-conformance and timely action to prevent occurrence.
  • Reduction in Quality Management System (QMS) non-conformances, and Customer Complaints & repeat process NC's.
  • Timely implementation of product, process, and Quality Management System changes.
  • Avoidance of product recalls.
  • Compliance with approved procedures.
  • Adherence to the QMS, GxP & Regulatory requirements.
  • Develop, generate, and maintain documentation to support an effective and compliant QMS, including:
  • Product Routers & Assemblies (PRA), Material (DRM) and Product Specifications
  • Product and Process FMEAs / Risk Assessments
  • Customer Complaints
  • Medical Device Risk Management Reports and Files
  • Quality Inspection Procedures and Control Plans
  • Quality Systems and Process SOPs and Work Instructions (PWI).
  • Conduct internal Audits, GMP and process audits, as required.
  • Supervise goods in inspection.
  • To accurately record data, calculate results and file information.
  • To actively participate in the investigation of quality issues (NC) and identify effective Corrective and Preventive Actions (CAPA) as required, in a timely manner.
  • To actively provide quality support to manufacturing.
  • Generate, review, update and maintain Quality procedures, test methods, instructions.
  • To actively provide quality support in batch records review and ensure correct batch release process.
  • To actively support training.
  • To actively support change control process.
  • To provide quality support for manufacturing improvement projects.
  • The jobholder has no budget setting responsibilities.
  • Any spend is subject to QM approval.
  • Use of various laboratory and computer equipment.
  • Limited Supervisory role.
  • Review testing activity results against specified acceptance criteria and relevant Out of Specification (OOS) test results, Non-conformances, MRB and CAPA's.
  • Consult with the QM should any test result fail to meet acceptance criteria or anticipated result.
  • Determination of priorities at the start of and throughout each shift.
  • Escalation to the Quality Manager on the root cause and identified actions arising from non-conformities and OOS results.
  • Work closely with Quality, Manufacturing, Supply Chain, and R&D departments.
  • Be prepared to work on project teams and at any AMS site as required by the QM.
  • Communicate verbally, one to one, in a group, on the telephone and via email within their immediate team, other departments and at all levels of the Company.
  • Maintain communication between departments (Quality, R&D and Production) on the status of Quality Projects and Investigations.
  • Be an active participant in Departmental, Operational and Project review meetings as required.


  • Bachelor of Science Degree in Engineering or Science-related field / 5 years Quality Assurance experience and experience withing manufacturing QE.
  • Required Knowledge, Skills, & Abilities:
  • Ability to represent the department in cross-functional interactions internally and externally.
  • Ability to provide solutions to difficult technical issues associated with specific projects.
  • Experience in medical device industry / Knowledge of ISO13485 & FDA QSR requirements.
  • Knowledge of world class quality techniques and implementation.
  • Good working knowledge of validation, data integrity, statistics, technical drawing and tolerancing.
  • Knowledge of Good Manufacturing Practice, Good Laboratory Practice and Quality Systems
  • Strong attention to detail.
  • Familiarity with appropriate software e.g. Minitab, MS Office, Lotus Notes.
  • Good organisational skills
  • Ability to identify and implement continual improvement initiatives.
  • Able to manage own time effectively, prioritise tasks and deliver to critical deadlines.
  • Good communication skills; written, verbal and presenting.
  • Able to work autonomously and as part of a multi-disciplinary team.
  • Flexible and adaptable to changing work environment.

Salary & Benefits

Up to 35,000 - 40,000 per annum

  • Annual incentive bonus
  • Life Cover
  • Penson contribution up to 6%
  • Dental Insurance
  • Employee share scheme

How to Apply

Apply now by submitting your CV below, alternatively you can send your CV to (url removed). Please include "Quality Engineer" in the subject line

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