Medical Device Quality Assurance Specialist
2 weeks ago
Industry: Medical Device Manufacturing
Location: Plymouth
Position Type: Permanent
About the Company:
Our client is a pioneering company in the UK-based medical device industry, specializing in advanced wound care and wound closure products. They are dedicated to developing and manufacturing world-leading solutions that enhance patient care.
Job Description:
Overview:
As a Quality Engineer, you will report to the Quality Manager and be responsible for technical documentation, project management, and coordination of projects with other departments. Your primary goal will be to maintain compliance with relevant cGMP, FDA QSR 21 CFR 820, ISO13485, and European Medical Devices Directive MDD94/42/EEC.
Key Responsibilities:
- Deputy to the Quality Manager
- Maintain and improve quality compliance
- Evaluate product and process risks in line with Medical Device Risk Management requirements
- Handle and investigate customer complaints
- Timely resolution of identified non-conformances and implementation of effective corrective action
- Reduce Quality Management System (QMS) non-conformances, customer complaints, and repeat process NCs
- Timely implementation of product, process, and Quality Management System changes
- Adhere to the QMS, GxP, and Regulatory requirements
- Product Routers and 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
- Provide quality support for manufacturing improvement projects
- Review testing activity results against specified acceptance criteria and relevant Out of Specification (OOS) test results, Non-conformances, MRB, and CAPAs
- 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 Quality Manager
- 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 projectsExperience in the medical device industry / Knowledge of ISO13485 and FDA QSR requirementsKnowledge of world-class quality techniques and implementationGood working knowledge of validation, data integrity, statistics, technical drawing, and tolerancingKnowledge of Good Manufacturing Practice, Good Laboratory Practice, and Quality SystemsFamiliarity with appropriate software e.g. Minitab, MS Office, Lotus NotesFlexible and adaptable to changing work environmentSalary and Benefits:
Up to £40,000 - £42,000 per annum
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, alternatively you can send your CV to (url removed). Please include "Quality Engineer" in the subject line.
-
Quality Assurance Specialist Medical Devices
3 weeks ago
Plymouth, Plymouth, United Kingdom Adecco Full timeJob Title: Quality Assurance SpecialistIndustry: Medical Device ManufacturingLocation: PlymouthPosition Type: PermanentAbout The Company:Adecco is proud to partner with a pioneering team at a UK-based company specializing in advanced wound care and wound closure products. This organization is dedicated to developing and manufacturing world-leading solutions...
-
Quality Assurance Specialist Medical Devices
3 weeks ago
Plymouth, Plymouth, United Kingdom Adecco Full timeJob Title: Quality Assurance SpecialistIndustry: Medical Device ManufacturingLocation: PlymouthPosition Type: PermanentAbout The Company:Adecco is proud to partner with a pioneering team at a UK-based company specializing in advanced wound care and wound closure products. This organization is dedicated to developing and manufacturing world-leading solutions...
-
Medical Device Quality Assurance Specialist
2 weeks ago
Plymouth, Plymouth, United Kingdom Adecco Full timeJob Title: Medical Device Quality EngineerJob Summary:We are seeking a highly skilled Medical Device Quality Engineer to join our team at a pioneering company specializing in advanced wound care and wound closure products. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality and compliance in our medical...
-
Medical Device Quality Assurance Specialist
2 weeks ago
Plymouth, Plymouth, United Kingdom Adecco Full timeJob Title: Medical Device Quality EngineerJob Summary:We are seeking a highly skilled Medical Device Quality Engineer to join our team at a pioneering company specializing in advanced wound care and wound closure products. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality and compliance in our medical...
-
Medical Device Quality Assurance Specialist
2 weeks ago
Plymouth, Plymouth, United Kingdom Adecco Full timeJob Title: Medical Device Quality EngineerJob Summary:We are seeking a highly skilled Medical Device Quality Engineer to join our team at a pioneering company in the UK. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality and compliance in the design, development, and manufacture of our medical...
-
Medical Device Quality Assurance Specialist
2 weeks ago
Plymouth, Plymouth, United Kingdom Adecco Full timeJob DescriptionAs a Quality Engineer for Medical Devices, you will be responsible for ensuring the quality and compliance of our medical devices. This includes maintaining and improving quality compliance, evaluating product and process risks, and handling customer complaints.Key Responsibilities:Deputy to the Quality ManagerMaintain and improve quality...
-
Medical Device Quality Assurance Specialist
2 weeks ago
Plymouth, Plymouth, United Kingdom https:www.energyjobline.comsitemap Full timeJob Title:Quality Assurance EngineerKey Responsibilities: Conduct Product and Process FMEAs / Risk Assessments Manage Customer Complaints Develop Medical Device Risk Management Reports and Files Create Quality Inspection Procedures and Control Plans Establish Quality Systems and Process SOPs and Work Instructions (PWI) Familiarity with appropriate software...
-
Medical Device Quality Assurance Specialist
2 weeks ago
Plymouth, Plymouth, United Kingdom fish4.co - Jobboard Full timeJob Title: Quality EngineerIndustry: Medical Device ManufacturingLocation: PlymouthPosition Type: PermanentAbout 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.Job Description:Overview:As a...
-
Medical Device Quality Assurance Specialist
2 weeks ago
Plymouth, Plymouth, United Kingdom Adecco UK LTD Full timeJob Title: Quality EngineerIndustry: Medical Device ManufacturingLocation: PlymouthPosition Type: PermanentAbout the CompanyAdecco UK LTD is a pioneering company specializing in advanced wound care and wound closure products. We are dedicated to developing and manufacturing world-leading solutions that enhance patient care. With a wealth of resources and...
-
Medical Device Quality Assurance Specialist
2 weeks ago
Plymouth, Plymouth, United Kingdom fish4.co - Jobboard Full timeJob Title: Quality EngineerIndustry: Medical Device ManufacturingLocation: PlymouthPosition Type: PermanentAbout the CompanyOur 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...
-
Medical Device Quality Assurance Specialist
2 weeks ago
Plymouth, Plymouth, United Kingdom Adecco UK LTD Full timeJob Title: Quality EngineerIndustry: Medical Device ManufacturingLocation: PlymouthPosition Type: PermanentAbout the CompanyAdecco UK LTD is a pioneering company specializing in advanced wound care and wound closure products. We are dedicated to developing and manufacturing world-leading solutions that enhance patient care. With a wealth of resources and...
-
Medical Device Quality Assurance Specialist
2 weeks ago
Plymouth, Plymouth, United Kingdom fish4.co - Jobboard Full timeJob Title: Quality EngineerIndustry: Medical Device ManufacturingLocation: PlymouthPosition Type: PermanentAbout The CompanyJoin 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...
-
Medical Device Quality Assurance Specialist
2 weeks ago
Plymouth, Plymouth, United Kingdom fish4.co - Jobboard Full timeJob Title: Quality EngineerIndustry: Medical Device ManufacturingLocation: PlymouthPosition Type: PermanentAbout the CompanyOur 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...
-
Quality Assurance Specialist
2 weeks ago
Plymouth, Plymouth, United Kingdom Adecco UK Limited Full timeJob Title: Quality Assurance SpecialistAbout the Role:As a Quality Assurance Specialist at Adecco UK Limited, you will be responsible for ensuring the quality of our medical devices meets the highest standards. You will work closely with our manufacturing and quality teams to identify and implement process improvements, ensuring compliance with regulatory...
-
Quality Assurance Specialist
2 weeks ago
Plymouth, Plymouth, United Kingdom Adecco Full time £40,000 - £42,000Quality Engineer Job Descriptionbrbr**Key Responsibilities:**brbr* Technical documentation and project managementbr* Coordination of projects with other departmentsbr* Maintenance of compliance to relevant cGMP, FDA QSR 21 CFR 820, ISO13485 & European Medical Devices Directive MDD94/42/EECbrbr**Quality Assurance:**brbr* Evaluate product & process...
-
Quality Assurance Specialist
2 days ago
Plymouth, Plymouth, United Kingdom Adecco UK Limited Full timeAbout the RoleWe are seeking a skilled Quality Engineer to join our team at Adecco UK Limited. As a Quality Engineer, you will play a key role in ensuring the quality of our medical device products and maintaining compliance with regulatory requirements.Key ResponsibilitiesTechnical documentation and project managementCoordination of projects with other...
-
Medical Device Support Specialist
7 days ago
Plymouth, Plymouth, United Kingdom On Target Recruitment Ltd Full timeA leading medical devices manufacturer with a family feel is seeking a Clinical Support Specialist to support theatre staff, assist in cases, and liaise with orthopaedic surgeons, consultants, and nurses.Key responsibilities include:Supporting sales reps in the South West regionChecking implants and conducting audits within the NHS and private...
-
Quality Assurance Specialist
2 weeks ago
Plymouth, Plymouth, United Kingdom Adecco Full timeJob DescriptionJob Title: Quality EngineerIndustry: Medical Device ManufacturingLocation: PlymouthPosition Type: PermanentAbout the CompanyAdecco is a leading provider of recruitment and workforce solutions. We are committed to helping our clients find the best talent for their businesses.Job SummaryWe are seeking a Quality Engineer to join our team in...
-
Quality Assurance Specialist
3 weeks ago
Plymouth, Plymouth, United Kingdom Adecco Full timeJob Title: Quality EngineerJob Summary:We are seeking a highly skilled Quality Engineer to join our team at Adecco. As a Quality Engineer, you will be responsible for ensuring the quality of our medical devices and maintaining compliance with regulatory requirements.Key Responsibilities:Technical documentation and project managementCoordination of projects...
-
Quality Assurance Specialist
3 weeks ago
Plymouth, Plymouth, United Kingdom Adecco Full timeJob Title: Quality EngineerJob Summary:We are seeking a highly skilled Quality Engineer to join our team at Adecco. As a Quality Engineer, you will be responsible for ensuring the quality of our medical devices and maintaining compliance with regulatory requirements.Key Responsibilities:Technical documentation and project managementCoordination of projects...
