At a Glance
- Tasks: Ensure medical devices meet quality standards and compliance through audits and system support.
- Company: Join a leading medical device company dedicated to advancing healthcare solutions.
- Benefits: Enjoy a dynamic work environment with opportunities for growth and development.
- Why this job: Make a real impact in healthcare while working with innovative technologies and a supportive team.
- Qualifications: A relevant degree in science or engineering and experience in Quality Systems are essential.
- Other info: We value diversity and encourage applications from all qualified candidates.
The predicted salary is between 36000 - 60000 £ per year.
We are currently looking for a Quality Assurance Engineer to join a leading medical device company based in the SEERS Medical area. As the Quality Assurance Engineer, you will be responsible for ensuring that products and services are fit for purpose, legally compliant, and meet customer expectations.
KEY DUTIES AND RESPONSIBILITIES:
- Support the development of the site Quality Management System (QMS) to meet business requirements.
- Conduct internal quality audits and prepare audit reports.
- Support preparation for customer, regulatory, and notified body audits.
- Provide guidance on non-conformances and support day-to-day manufacturing operations.
ROLE REQUIREMENTS:
- Relevant degree in a scientific or engineering discipline.
- Proven industry experience in Quality Systems and their operational implementation.
- A working knowledge and practical experience with ISO 13485, CAPA requirements, GDP, and GMP.
Quality Assurance Engineer - Med Device employer: Hyper Recruitment Solutions
Contact Detail:
Hyper Recruitment Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Engineer - Med Device
✨Tip Number 1
Familiarise yourself with ISO 13485 and other relevant standards. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to quality assurance in the medical device industry.
✨Tip Number 2
Network with professionals in the medical device sector. Attend industry events or join online forums to connect with others who can provide insights and potentially refer you to job openings.
✨Tip Number 3
Prepare for technical questions related to Quality Management Systems and internal audits. Being able to discuss your practical experience and how you've handled non-conformances will set you apart from other candidates.
✨Tip Number 4
Research the company’s products and recent developments in the medical device field. Showing that you are knowledgeable about their specific challenges and innovations can make a strong impression during your interview.
We think you need these skills to ace Quality Assurance Engineer - Med Device
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in Quality Systems and any specific knowledge of ISO 13485, CAPA, GDP, and GMP. Use keywords from the job description to demonstrate your fit for the role.
Craft a Strong Cover Letter: In your cover letter, explain why you are passionate about quality assurance in the medical device industry. Mention specific examples from your past experience that align with the key duties and responsibilities outlined in the job description.
Highlight Relevant Qualifications: Clearly state your degree in a scientific or engineering discipline and any additional certifications related to quality assurance. This will help establish your credibility and suitability for the role.
Prepare for Potential Questions: Think about how you would respond to questions regarding your experience with internal audits and regulatory compliance. Be ready to discuss specific situations where you provided guidance on non-conformances or supported manufacturing operations.
How to prepare for a job interview at Hyper Recruitment Solutions
✨Know Your Standards
Familiarise yourself with ISO 13485, CAPA, GDP, and GMP. Be prepared to discuss how you've applied these standards in your previous roles, as this will demonstrate your practical knowledge and relevance to the position.
✨Showcase Your Audit Experience
Highlight any experience you have with conducting internal audits or preparing for external audits. Discuss specific examples where your contributions led to improvements in quality management systems or compliance.
✨Understand the QMS
Be ready to talk about your experience with Quality Management Systems. Explain how you've supported their development and implementation in past roles, and how you can contribute to the company's QMS.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills. Think of examples where you've dealt with non-conformances or supported manufacturing operations, and be ready to explain your thought process and actions.