Quality Engineer (Medical Devices)

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.

Overview

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.
  
  

Qualifications

• 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 £40,000 - £42,000 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 [email protected]. Please include "Quality Engineer" in the subject line