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- Tasks: Lead quality assurance activities for medical devices, ensuring compliance with regulations.
- Company: Join a dynamic team in the medical device industry focused on quality and innovation.
- Benefits: Competitive salary, opportunities for professional growth, and a collaborative work environment.
- Why this job: Make a real impact on product quality and patient safety while working with cutting-edge technology.
- Qualifications: Bachelor’s degree in engineering or related field; 3+ years in Quality Assurance in medical devices.
- Other info: On-site position in Leeds with a focus on continuous improvement and teamwork.
The predicted salary is between 40000 - 45000 £ per year.
Job Title: Quality Assurance Manager (Medical Devices)
Location: Leeds (UK)
Job Type: Full-time, on site
Reports to: QARA Director
Salary range: 40,000.00 – 45,000.00 GBP
Job Description:
We are seeking an experienced and highly motivated Quality Assurance Manager to join our team in the medical device industry. The ideal candidate will have extensive experience in ensuring the quality and compliance of medical devices, with a strong background in ISO 13485 , Medical Device Regulation (MDR) , and FDA regulations . As a Quality Assurance Manager, you will be responsible for leading and overseeing all quality-related activities, ensuring that our products meet regulatory and customer requirements.
Key Responsibilities:
- Ensure adherence to quality standards and regulatory requirements.
- Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485 , MDR , and FDA regulations.
- Coordinate internal and external audits, including preparation, execution, and follow-up activities.
- Oversee product lifecycle quality control, from design and development through to manufacturing and post-market surveillance.
- Ensure compliance with regulatory bodies (FDA, Notified Bodies) and relevant standards, preparing and managing documentation for regulatory submissions.
- Review and approve validation, verification, and test plans to ensure product quality and regulatory compliance.
- Lead the CAPA (Corrective and Preventive Action) process, ensuring timely and effective resolution of non-conformances.
- Provide quality assurance guidance to cross-functional teams, including R&D, manufacturing, and supply chain.
- Stay up to date with the latest industry regulations, standards, and best practices to continuously improve the quality management system.
Key Qualifications:
- Bachelor’s degree in engineering, or related field (Master’s preferred).
- Minimum of 3 years of experience in Quality Assurance, specifically within the medical device industry.
- In-depth knowledge of ISO 13485 , MDR , and FDA regulations.
- Proven experience in managing or leading Quality Assurance teams.
- Strong understanding of risk management, CAPA, and product lifecycle management.
- Excellent problem-solving skills with a focus on continuous improvement.
- Strong communication and interpersonal skills, capable of working across multiple departments.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Medical Device
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Quality Assurance Manager employer: Atlas Endoscopy
Contact Detail:
Atlas Endoscopy Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Manager
✨Tip Number 1
Familiarize yourself with the latest updates in ISO 13485, MDR, and FDA regulations. Being well-versed in these standards will not only boost your confidence during 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, especially those who are already working in quality assurance roles. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the field.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully implemented quality management systems or led CAPA processes in your previous roles. Real-life scenarios can showcase your problem-solving skills and your ability to drive continuous improvement.
✨Tip Number 4
Research StudySmarter's approach to quality assurance and familiarize yourself with our products. Understanding our mission and values will help you align your answers during the interview and show that you're genuinely interested in joining our team.
We think you need these skills to ace Quality Assurance Manager
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Quality Assurance Manager position. Understand the key responsibilities and qualifications required, especially focusing on ISO 13485, MDR, and FDA regulations.
Tailor Your CV: Customize your CV to highlight relevant experience in quality assurance within the medical device industry. Emphasize your knowledge of regulatory standards and any leadership roles you've held.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your passion for quality assurance and your understanding of the medical device sector. Mention specific experiences that align with the responsibilities listed in the job description.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. A polished application reflects your attention to detail, which is crucial for a Quality Assurance Manager.
How to prepare for a job interview at Atlas Endoscopy
✨Show Your Knowledge of Regulations
Make sure to demonstrate your understanding of ISO 13485, MDR, and FDA regulations during the interview. Prepare specific examples of how you've applied these standards in your previous roles, as this will show your expertise and readiness for the position.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills and ability to handle quality assurance challenges. Think of past experiences where you successfully led CAPA processes or managed audits, and be ready to discuss them in detail.
✨Highlight Your Leadership Experience
Since the role involves leading Quality Assurance teams, be prepared to talk about your leadership style and experiences. Share examples of how you've motivated teams, resolved conflicts, and ensured compliance across departments.
✨Stay Updated on Industry Trends
Demonstrate your commitment to continuous improvement by discussing recent changes in medical device regulations or quality management practices. This shows that you are proactive and dedicated to staying informed in a rapidly evolving industry.
