Job Description
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 eg 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 (see below) Please include "Quality Engineer" in the subject line