At a Glance
- Tasks: Support quality management systems and ensure compliance with industry regulations.
- Company: First Water Ramsbury Ltd, part of Gentell, focused on quality assurance.
- Benefits: Competitive salary, opportunities for growth, and a collaborative work environment.
- Other info: Great chance to develop skills and advance your career in a supportive setting.
- Why this job: Join a dynamic team and make a real impact in the medical device industry.
- Qualifications: Experience in quality assurance and knowledge of regulatory standards.
The predicted salary is between 37500 - 48500 £ per year.
Pay: £37,500.00 - £48,500.00 per year
POSITION TITLE: DHF Process Quality Engineer
REPORTS TO: QA Manager
LOCATION: First Water Ramsbury Ltd, Ramsbury
PURPOSE OF THE ROLE
The DHF Process 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
- Support the preparation and maintenance of DHF and Technical Files for CE marking and international registrations.
- Work cross-functionally with R&D, Quality Assurance, Regulatory Affairs, and Manufacturing teams to collect and integrate necessary documentation.
- Project manage activities simultaneously to ensure timely, compliant documents are generated to support Tech File submissions for new product launches.
- Maintain document control systems, including version control, approval workflows, and archiving per company procedures.
- Review and edit technical content for accuracy, completeness, and compliance.
- Design artworks for packaging using appropriate software.
- Support internal and external audits and inspections by providing required documentation and addressing any document-related findings.
- Supplier Management and perform supplier audits.
- Execute and support activities to ensure effective monitoring of supplier performance including supplier corrective actions.
- Provide technical expertise regarding validations, verification and qualifications.
- Assess current products or services and identifying quality issues.
- Determining performance indicators for a product or service’s quality.
- Assist in the continuous improvement of documentation processes and templates to increase efficiency and ensure compliance.
- Train staff on documentation and DHF best practices as needed.
- Support External / regulatory or customer audits.
- Any other activities delegated by the Quality Manager.
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.
Quality Engineer - Fabrications employer: Gentell
First Water Ramsbury Ltd offers a dynamic and supportive work environment for Quality Engineers, fostering a culture of continuous improvement and collaboration. Located in the picturesque village of Ramsbury, employees benefit from a strong commitment to professional development, competitive salaries, and a focus on compliance with industry standards. Join us to be part of a team that values quality and innovation in the medical device sector.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Engineer - Fabrications
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their quality management systems and regulations they comply with. This will show you're genuinely interested and ready to contribute from day one.
✨Tip Number 3
Practice your responses to common interview questions, especially those related to quality assurance and compliance. Use the STAR method (Situation, Task, Action, Result) to structure your answers and highlight your achievements.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Quality Engineer - Fabrications
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Engineer role. Highlight your experience with Quality Management Systems and any relevant certifications like ISO 13485:2016. We want to see how your skills align with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance and how you can contribute to our team at First Water Ramsbury Ltd. Keep it concise but impactful!
Showcase Your Technical Skills:Don’t forget to mention your technical expertise, especially in areas like document control systems and supplier management. We love candidates who can demonstrate their knowledge of compliance and regulatory standards.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at Gentell
✨Know Your Standards
Familiarise yourself with ISO 13485:2016 and the EU MDR regulations. Being able to discuss these standards confidently will show that you understand the compliance landscape and are ready to contribute to the Quality Management System.
✨Showcase Your Cross-Functional Skills
Prepare examples of how you've worked with different teams, like R&D or Manufacturing. Highlighting your ability to collaborate across departments will demonstrate that you can effectively manage projects and integrate necessary documentation.
✨Be Ready for Technical Questions
Brush up on your knowledge of document control systems and technical file preparation. Expect questions about how you would handle audits or address document-related findings, so have specific scenarios in mind to illustrate your expertise.
✨Continuous Improvement Mindset
Think of ways you've contributed to process improvements in previous roles. Be prepared to discuss how you can help enhance documentation processes and templates at First Water Ramsbury Ltd, showing your commitment to quality and efficiency.
