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 £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 . Please include "Quality Engineer" in the subject line