At a Glance
- Tasks: Support product development and ensure compliance with global quality standards.
- Company: Join a leading medical device company making a difference in healthcare.
- Benefits: Enjoy a hybrid work model and competitive salary with additional perks.
- Why this job: Be part of innovative projects that impact lives in a collaborative environment.
- Qualifications: Degree in Engineering or Life Sciences with 5+ years in medical device quality.
- Other info: Opportunity to drive product quality from concept to launch.
The predicted salary is between 43200 - 72000 £ per year.
Senior Quality Engineer – Medical Devices
Hybrid | South East / Home Counties | Circa £60,000 + Benefits
A leading medical device company is seeking a Senior Quality Engineer to support product development and change control activities. This role will ensure compliance with global standards including ISO 13485, ISO 14971, 21 CFR Part 820, and EU MDR.
You\’ll act as the Quality representative across cross-functional teams, applying expertise in risk management, design controls, and CAPA to drive product and process quality from concept to launch.
Key Requirements:
- Degree in Engineering or Life Sciences
- 5+ years\’ experience in Quality within medical devices
- Strong knowledge of ISO 13485, ISO 14971, FDA QSRs
- ASQ CQE preferred or willingness to obtain
This is a great opportunity for an experienced Quality Engineer to contribute to meaningful product innovation in a collaborative, growth-focused environment.
Apply now for more details.
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Snr Design Quality Engineer employer: Roc Search GmbH
Contact Detail:
Roc Search GmbH Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Snr Design Quality Engineer
✨Tip Number 1
Network with professionals in the medical device industry. Attend relevant conferences or webinars where you can meet people who work in quality engineering roles. This can help you gain insights into the company culture and potentially get a referral.
✨Tip Number 2
Familiarise yourself with the latest developments in ISO standards and FDA regulations. Being well-versed in these areas will not only boost your confidence but also demonstrate your commitment to staying updated in the field.
✨Tip Number 3
Prepare to discuss specific examples of how you've applied risk management and design controls in previous roles. Having concrete stories ready will showcase your expertise and problem-solving skills during interviews.
✨Tip Number 4
Research the company’s recent projects and innovations in medical devices. Understanding their product line and challenges they face will allow you to tailor your discussions and show how you can add value to their team.
We think you need these skills to ace Snr Design Quality Engineer
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to understand the key requirements and responsibilities of the Senior Quality Engineer position. Tailor your application to highlight your relevant experience in medical devices and compliance with global standards.
Highlight Relevant Experience: In your CV and cover letter, emphasise your 5+ years of experience in quality engineering within the medical device sector. Be specific about your knowledge of ISO 13485, ISO 14971, and FDA QSRs, as these are crucial for the role.
Showcase Your Skills: Demonstrate your expertise in risk management, design controls, and CAPA in your application. Use concrete examples from your past work to illustrate how you've driven product and process quality from concept to launch.
Craft a Compelling Cover Letter: Write a personalised cover letter that connects your background and skills to the company's mission and values. Express your enthusiasm for contributing to meaningful product innovation and your willingness to collaborate in a growth-focused environment.
How to prepare for a job interview at Roc Search GmbH
✨Know Your Standards
Familiarise yourself with ISO 13485, ISO 14971, and 21 CFR Part 820. Be prepared to discuss how you've applied these standards in your previous roles, as this will demonstrate your expertise and understanding of compliance in the medical device industry.
✨Showcase Your Experience
With over 5 years in Quality within medical devices, be ready to share specific examples of projects you've worked on. Highlight your role in product development and change control activities, focusing on how you contributed to ensuring product quality from concept to launch.
✨Emphasise Cross-Functional Collaboration
As a Quality representative, you'll work with various teams. Prepare to discuss how you've successfully collaborated with cross-functional teams in the past, and provide examples of how your input has positively impacted product quality and compliance.
✨Prepare for Risk Management Questions
Risk management is crucial in this role. Be ready to explain your approach to risk assessment and mitigation, particularly in relation to design controls and CAPA. Use real-life scenarios to illustrate your problem-solving skills and decision-making process.