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For Companies At a Glance
- Tasks: Support quality and regulatory functions in medical device development and manufacturing.
- Company: Join a leading company dedicated to enhancing healthcare through innovative medical devices.
- Benefits: Enjoy flexible working options, professional development opportunities, and a collaborative team culture.
- Why this job: Make a real impact on global health standards while working with diverse teams.
- Qualifications: Bachelor's degree in Engineering and 4+ years of relevant industry experience required.
- Other info: Ideal for detail-oriented individuals passionate about quality assurance in healthcare.
The predicted salary is between 36000 - 60000 £ per year.
Purpose of the Role: As a Quality Engineer, you will play a key role in supporting and enhancing the Quality and Regulatory functions within the business. This position is focused on ensuring that product development and manufacturing processes meet global regulatory and quality standards. You will work cross-functionally with design, marketing, and compliance teams to ensure robust quality documentation, regulatory submissions, and QMS compliance are consistently maintained.
Main Duties & Responsibilities:
- Provide quality and regulatory support to the design team to ensure documentation meets EU MDR, UK MDR, and ISO 13485 requirements.
- Lead and contribute to the creation and remediation of technical documentation, including authoring essential components of technical files.
- Support the development of regulatory strategy in collaboration with marketing, ensuring timely execution of global product registrations.
- Write, review, and improve procedures, templates, and forms that support the quality and regulatory functions.
- Assist in maintaining and improving the company’s Quality Management System in line with ISO 13485 and ISO 14971.
- Support CAPA investigations, internal audits, and implementation of corrective actions.
- Ensure labelling, Instructions for Use (IFU), and packaging meet global regulatory requirements.
- Stay current with global regulatory intelligence and support the business in maintaining compliance across all markets.
- Assist in quality activities related to product testing, verification, and validation, where appropriate.
Key Focus Areas:
- EU MDR & UK MDR Compliance
- Technical File Creation & Remediation
- Global Regulatory Submissions & Intelligence
- Labelling & Packaging Compliance
- ISO 13485 QMS Development & Maintenance
- CAPA Management & Internal Audit Support
- Risk Management and Usability Documentation (e.g. RMF, CER, PMCF)
Qualifications, Skills, and Experience:
Essential:
- Solid understanding of EU MDR and UK MDR requirements.
- Proven experience in authoring or leading the development of technical documentation (e.g., Clinical Evaluation Reports, Risk Management Files, PMCF).
- Familiarity with labelling and packaging regulatory requirements.
- Experience with global product registrations and working with notified bodies or regulatory authorities.
- Knowledge of ISO 13485 and ISO 14971 standards.
- Strong communication and collaboration skills with internal teams and external partners.
This candidate will be responsible for the development, implementation, maintenance, and improvement of quality assurance processes. Throughout the implementation and maintenance process, this candidate should use data analysis to better understand quality reporting measures and improve processes.
Responsibilities:
- Perform problem identification, resolution, loss reporting and continuous improvement.
- Design and implement methods for process control, process improvement, testing and inspection.
- Develop, execute, and analyze quality reporting measures.
- Participate in internal and external quality audits.
Qualifications:
- Bachelor's degree or equivalent in Mechanical, Electrical, or Manufacturing Engineering.
- 4+ years' of industry experience.
- Strong knowledge of quality tools used in the industry.
- Analytical and quantitative approach to problem solving.
Locations
Quality Engineer (Medical Devices) employer: Arevna
Contact Detail:
Arevna Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Engineer (Medical Devices)
✨Tip Number 1
Familiarise yourself with the latest updates on EU MDR and UK MDR regulations. This knowledge will not only help you in interviews but also demonstrate your commitment to staying current in the field.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who work in quality assurance. Attend relevant conferences or webinars to make connections and learn about potential job openings.
✨Tip Number 3
Prepare to discuss specific examples of your experience with technical documentation and regulatory submissions. Being able to articulate your past successes will set you apart from other candidates.
✨Tip Number 4
Showcase your analytical skills by being ready to discuss how you've used data analysis to improve quality processes in previous roles. This will highlight your problem-solving abilities and fit for the role.
We think you need these skills to ace Quality Engineer (Medical Devices)
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Quality Engineer position. Familiarise yourself with EU MDR, UK MDR, and ISO 13485 standards as these are crucial for the role.
Tailor Your CV: Customise your CV to highlight relevant experience in quality engineering, particularly in medical devices. Emphasise your familiarity with technical documentation, regulatory submissions, and quality management systems.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your passion for quality assurance in medical devices. Mention specific experiences that demonstrate your ability to meet regulatory requirements and improve quality processes.
Highlight Relevant Skills: In your application, clearly outline your skills related to problem-solving, data analysis, and collaboration. Provide examples of how you've successfully contributed to quality improvement initiatives in previous roles.
How to prepare for a job interview at Arevna
✨Know Your Regulations
Make sure you have a solid understanding of EU MDR and UK MDR requirements. Brush up on ISO 13485 and ISO 14971 standards, as these will likely come up during the interview.
✨Showcase Your Documentation Skills
Be prepared to discuss your experience in authoring technical documentation. Highlight specific examples, such as Clinical Evaluation Reports or Risk Management Files, to demonstrate your expertise.
✨Emphasise Collaboration
Quality Engineers often work cross-functionally. Share examples of how you've successfully collaborated with design, marketing, and compliance teams to achieve quality and regulatory goals.
✨Prepare for Problem-Solving Questions
Expect questions that assess your analytical and quantitative problem-solving skills. Think of scenarios where you've identified issues and implemented effective solutions in quality assurance processes.
