POSITION TITLE: Quality Engineer REPORTS TO: QA Manager
LOCATION: First Water Ramsbury Ltd, Ramsbury
PURPOSE OF THE ROLE
The Quality Engineer is a key member of the Quality Assurance team at First Water Ramsbury Ltd, a Gentell company. The role is responsible for supporting and maintaining an effective Quality Management System (QMS) in compliance with ISO 13485:2016, EU MDR 2017/745, UK MDR 2002 (as amended), and MDSAP requirements.
The position supports the QA Manager in ensuring that products and processes consistently meet regulatory, customer, and internal quality requirements, while driving continuous improvement across site operations.
KEY RESPONSIBILITIES
Specific responsibilities include, but are not limited to:
· Perform duties as assigned by the QA Manager
· Maintain and support the effectiveness of the Quality Management System (QMS) in compliance with ISO 13485, EU MDR, UK MDR, and MDSAP requirements
· Ensure compliance with internal procedures, technical documentation, and applicable regulatory requirements
· Support document control, change control, and quality record management activities
· Monitor and ensure compliance with internal quality systems and external regulatory standards
· Support implementation and maintenance of procedures aligned to ISO 13485, EU MDR Annex I and II, and UK MDR requirements
· Support supplier audit activities, including preparation, participation, and follow-up of supplier audits
· Lead and/or support nonconformance investigations using structured methodologies (e.g. 5-Why, Fishbone)
· Drive and support CAPA activities in accordance with ISO 13485 and MDSAP expectations
· Support risk management activities in accordance with ISO 14971, including FMEA and risk assessments
· Ensure alignment between risk management, CAPA, complaints, and post-market data
· Provide technical support for validation and qualification activities (IQ/OQ/PQ, process validation, test method validation/verification, equipment qualification)
· Ensure validation and verification activities are planned, executed, and documented in compliance with applicable standards
· Analyse product and process performance data to identify trends and improvement opportunities
· Define, monitor, and report Key Performance Indicators (KPIs) related to product and process quality
· Lead or support continuous improvement initiatives across manufacturing and quality systems
· Support new product introduction and product/process changes through structured change control processes
· Perform internal audits in accordance with ISO 13485 and MDSAP requirements
· Support external audits including Notified Body, UKCA, MDSAP, customer, and regulatory inspections
· Support audit readiness activities and timely closure of audit findings
· Support complaint handling, investigation, and trending activities
· Contribute to post-market surveillance (PMS) activities in line with EU MDR and UK MDR requirements
· Identify, escalate, and support investigation of adverse trends or quality issues
· Prepare and present quality metrics and reports for management review
· Provide technical expertise and quality support to cross-functional teams (Operations, Regulatory, R&D)
· Participate in training activities and promote best practices in quality and compliance
· Support a culture of quality, compliance, and continuous improvement across the organization
COMPLIANCE & REGULATORY ALIGNMENT
This role directly supports compliance with:
- ISO 13485:2016 – Quality Management Systems for Medical Devices
- EU MDR 2017/745 – Medical Device Regulation
- UK MDR 2002 (as amended) – UK Medical Device Regulations
- MDSAP – Medical Device Single Audit Program
- ISO 14971:2019 – Risk Management for Medical Devices
- Applicable FDA QSR (21 CFR Part 820) principles where relevant
EEO STATEMENT
We are an Equal Employment Opportunity Employer and do not discriminate against applicants based on race, age, religion, sex, sexual orientation, gender identity, disability, or any other protected characteristic.
Pay: £30,000.00-£40,000.00 per year
Work Location: In person
