Medical Device Quality Assurance Specialist

2 weeks ago

Plymouth, Plymouth, United Kingdom fish4.co - Jobboard Full time
Job Title: Quality Engineer

Industry: Medical Device Manufacturing

Location: Plymouth

Position Type: Permanent

About the Company

Our client is a pioneering company in the field of advanced wound care and wound closure products. They are 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

Overview

The Quality Engineer will report to the Quality Manager and be responsible for technical documentation, project management, and coordination of projects with other departments. This role will aid in the maintenance of compliance to relevant cGMP, FDA QSR 21 CFR 820, ISO13485, and European Medical Devices Directive MDD94/42/EEC.

Key Responsibilities
  • Deputy to the QM
  • Maintain and improve quality compliance
  • Evaluate product and process risks in line with Medical Device Risk Management requirements
  • Handling and investigation of Customer complaints
  • Timely resolution of identified non-conformances and implementation of effective corrective action
  • 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
  • Adherence to the QMS, GxP & Regulatory requirements
  • 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)
  • Supervise goods in inspection
  • Accurately record data, calculate results and file information
  • Actively participate in the investigation of quality issues (NC) and identify effective Corrective and Preventive Actions (CAPA) as required, in a timely manner
  • Provide quality support to manufacturing
  • Generate, review, update and maintain Quality procedures, test methods, instructions
  • Support training and change control process
  • Provide quality support for manufacturing improvement projects
  • Use of various laboratory and computer equipment
  • Review testing activity results against specified acceptance criteria and relevant Out of Specification (OOS) test results, Non-conformances, MRB and CAPA's
  • Determine priorities at the start of and throughout each shift
  • Escalate 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
Qualifications
  • Bachelor of Science Degree in Engineering or Science-related field/5 years Quality Assurance experience and experience within manufacturing QE
  • 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
  • Familiarity with appropriate software e.g., Minitab, MS Office, Lotus Notes
  • Flexible and adaptable to changing work environment

Benefits

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

How to Apply

Apply now by submitting your CV below; Please include "Quality Engineer" in the subject line.

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