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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 the medical device sector.
- Other info: ASQ Certified Quality Engineer certification is needed within one year of joining.
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 roles. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in design quality engineering.
✨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 you can discuss these standards with others and gain insights into their practical application in the field.
✨Tip Number 3
Prepare to demonstrate your analytical skills by reviewing case studies or examples of how you've used advanced quality tools in past roles. Be ready to discuss specific instances where your interventions led to improved compliance or product quality.
✨Tip Number 4
Showcase your collaborative skills by thinking of examples where you've worked effectively with cross-functional teams. Highlight your ability to communicate complex quality concepts to non-technical stakeholders, as this will be crucial in a role that requires teamwork across various departments.
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 compliance with medical device regulations. Emphasise your familiarity with ISO 13485, ISO 14971, and 21 CFR Part 820, as these are crucial for the role.
Craft a Compelling Cover Letter: In your cover letter, express your passion for contributing to life-saving technologies. Mention specific examples of how you've embedded quality into product design and your experience with advanced quality tools like risk management and CAPA.
Showcase Your Analytical Skills: Highlight your analytical mindset by providing examples of how you've interpreted data to identify trends and improve processes. This will demonstrate your ability to contribute to continuous improvement initiatives.
Prepare for Potential Questions: Think about how you would respond to questions regarding your experience with cross-functional collaboration and managing product changes. Be ready to discuss specific projects where you successfully resolved on-market product issues.
How to prepare for a job interview at Halian Technology Limited
✨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 regulatory compliance.
✨Showcase Your Analytical Skills
Prepare examples that highlight your analytical mindset. Discuss specific instances where you interpreted data to identify trends or risks, and how those insights led to actionable improvements in product quality.
✨Emphasise Collaboration
Since the role involves working with cross-functional teams, be ready to share experiences where you successfully collaborated with engineering and manufacturing teams. Highlight how you contributed to design reviews or managed product changes.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills. Think about past challenges you've faced in quality assurance and how you resolved them, particularly in relation to CAPA and risk management.
