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For Companies At a Glance
- Tasks: Lead quality assurance for life-saving medical devices and ensure compliance with global standards.
- Company: Join a top-tier global medical device company based in Kent, making a real impact.
- Benefits: Enjoy competitive pay, career growth opportunities, and a chance to work on innovative technologies.
- Why this job: Be part of a mission-driven team that values quality and innovation in healthcare.
- Qualifications: Requires a degree in Engineering and 7 years of experience in medical device quality.
- Other info: ASQ Certified Quality Engineer certification is needed within the first year.
The predicted salary is between 48000 - 72000 £ per year.
Halian is seeking a highly skilledSenior Design Quality Engineerto join a leading global medical device business based in Kent. This is a fantastic opportunity to contribute to the development of life-saving technologies while ensuring compliance with international quality and regulatory standards.
Key Responsibilities
- Lead quality assurance activities across product development and manufacturing.
- Ensure compliance with ISO 13485, ISO 14971, 21 CFR Part 820, and other relevant standards.
- Act as the Quality Core Team Member, embedding quality into every stage of product design and realisation.
- Apply advanced quality tools including risk management, design controls, verification and validation, CAPA, and statistical analysis.
- Support regulatory compliance efforts, including audit readiness and responses to global regulatory bodies.
- Develop and maintain product risk management files in accordance with ISO 14971.
- Collaborate with cross-functional teams to manage product changes, participate in design reviews, and support design transfers.
- Monitor global product data to identify trends, risks, and opportunities for improvement.
- Provide guidance on resolving on-market product issues and escalate critical concerns to senior leadership.
- Contribute to special projects and continuous improvement initiatives.
Skills & Experience
- Strong understanding of Quality Management Systems and their integration with risk management, CAPA, complaints, and document control.
- In-depth knowledge of medical device regulations and standards.
- Proven ability to conduct complex investigations and apply systems thinking across hardware, software, and consumables.
- Analytical mindset with the ability to interpret data and identify patterns leading to actionable insights.
- Effective collaboration with engineering and manufacturing teams.
Qualifications
- Bachelors degree in Engineering (Electrical, Mechanical, Biomedical, Software) or a related field.
- Minimum 7 years of experience in R&D or Quality within the medical device industry.
- ASQ Certified Quality Engineer (CQE) certification required or must be obtained within one year.
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Senior Design Quality Engineer employer: Halian Technology Limited
Contact Detail:
Halian Technology Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Design Quality Engineer
✨Tip Number 1
Network with professionals in the medical device industry, especially those who have experience in quality assurance. Attend relevant conferences or webinars to meet potential colleagues and learn about the latest trends in quality management systems.
✨Tip Number 2
Familiarise yourself with the specific ISO standards mentioned in the job description, such as ISO 13485 and ISO 14971. Consider joining online forums or groups where these topics are discussed to deepen your understanding and show your commitment to compliance.
✨Tip Number 3
Prepare to discuss your experience with advanced quality tools during interviews. Think of specific examples where you've successfully applied risk management, design controls, or statistical analysis in your previous roles, as this will demonstrate your hands-on expertise.
✨Tip Number 4
Research the company’s recent projects and initiatives in the medical device sector. Being knowledgeable about their products and challenges will allow you to tailor your discussions and show how you can contribute to their goals effectively.
We think you need these skills to ace Senior Design Quality Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality assurance and medical device regulations. Emphasise your familiarity with ISO standards and any specific projects that demonstrate your skills in risk management and compliance.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the medical device industry and your understanding of the role. Mention specific experiences that align with the responsibilities listed in the job description, such as leading quality assurance activities or collaborating with cross-functional teams.
Highlight Relevant Certifications: If you have an ASQ Certified Quality Engineer (CQE) certification, make sure to mention it prominently. If you are in the process of obtaining it, include that information as well, along with your commitment to achieving it within the required timeframe.
Showcase Analytical Skills: Provide examples in your application that demonstrate your analytical mindset. Discuss how you've used data interpretation to identify trends or improve processes in previous roles, particularly in relation to product quality and compliance.
How to prepare for a job interview at Halian Technology Limited
✨Showcase Your Quality Management Knowledge
Make sure to highlight your understanding of Quality Management Systems, especially how they integrate with risk management and CAPA. Be prepared to discuss specific examples from your past experience that demonstrate your expertise in these areas.
✨Familiarise Yourself with Relevant Standards
Since the role requires compliance with ISO 13485, ISO 14971, and 21 CFR Part 820, it’s crucial to brush up on these standards. Be ready to explain how you have applied these regulations in previous roles and how you would ensure compliance in this new position.
✨Prepare for Technical Questions
Expect to face technical questions related to advanced quality tools like risk management and statistical analysis. Practise articulating your thought process when using these tools, as well as any challenges you've faced and how you overcame them.
✨Demonstrate Collaborative Skills
This role involves working closely with cross-functional teams, so be prepared to discuss your experience in collaboration. Share examples of how you’ve successfully worked with engineering and manufacturing teams to manage product changes or resolve issues.
