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

Overview

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 schemeHow 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