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- Tasks: Conduct internal audits to ensure compliance with quality standards and regulations.
- Company: Join a global medical device organisation dedicated to improving lives through advanced transplant technology.
- Benefits: Enjoy a dynamic work environment with opportunities for professional growth and development.
- Why this job: Be part of a mission-driven team that values quality and innovation in healthcare.
- Qualifications: University degree in a scientific field and 3 years of experience in medical device quality auditing required.
- Other info: Lead auditor certification in ISO 13485 or similar is a plus.
The predicted salary is between 30000 - 50000 £ per year.
As part of its continued growth, a dynamic and global medical device organization are seeking a meticulous and organized Quality Specialist, Internal Auditor – QMS to join its team. They are dedicated to improving lives through advanced transplant technology.
The Internal Auditor – QMS is responsible for conducting internal audits across global sites to ensure compliance with company policies, quality standards, and applicable regulations. The ideal candidate will possess excellent attention to detail, strong organizational abilities, and a background in conducting thorough, value-added audits that support ongoing quality system improvements. This role is vital for ensuring that company operations align with the Quality Management System (QMS).
Responsibilities:- Conduct internal audits to ensure compliance with FDA 21 CFR Part 820, ISO 13485, EU MDR, and other applicable standards.
- Evaluate organizational processes against defined quality standards.
- Identify areas for improvement and propose corrective actions within the QMS.
- Perform risk assessments and analyze audit outcomes to detect trends or systemic issues.
- Prepare and present detailed audit reports to management.
- Support development and implementation of corrective action plans based on audit findings.
- Provide training and guidance to staff regarding quality standards and QMS principles.
- Monitor and verify the effectiveness of implemented corrective actions.
- Stay informed on the latest developments in relevant quality standards and regulations.
- Comply with the company’s Code of Conduct and all other corporate policies.
- University or college degree, preferably in a scientific or quality/regulatory discipline.
- Minimum of 3 years of experience in medical device quality auditing, or a comparable combination of education and experience.
- In-depth knowledge of medical device regulations including FDA QSR, ISO 13485, ISO 14971, EU MDR, MDSAP, and CMDR.
- Strong analytical skills and a focus on process improvement.
- Ability to present findings clearly and respond professionally to stakeholders including management, customers, and suppliers.
- High emotional intelligence and professional demeanor to ensure positive engagement with auditees during audits.
- Proficiency in Microsoft Office tools (Excel, PowerPoint, Visio, Word, Access).
- Strong organizational and time-management skills.
- Experience in quality audits preferred; lead auditor certification in ISO 13485, MDR, or MDSAP is an asset.
Quality Assurance Specialist employer: Skills Alliance
Contact Detail:
Skills Alliance Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Specialist
✨Tip Number 1
Familiarise yourself with the specific regulations and standards mentioned in the job description, such as FDA 21 CFR Part 820 and ISO 13485. This knowledge will not only help you during the interview but also demonstrate your commitment to the role.
✨Tip Number 2
Prepare examples from your past experience where you've successfully conducted audits or implemented quality improvements. Being able to discuss these instances will showcase your practical skills and understanding of quality management systems.
✨Tip Number 3
Network with professionals in the medical device industry, especially those who have experience in quality assurance. Engaging with them can provide insights into the company culture and expectations, which can be beneficial during your application process.
✨Tip Number 4
Stay updated on the latest trends and changes in quality standards and regulations relevant to the medical device sector. This will not only prepare you for potential interview questions but also show your proactive approach to professional development.
We think you need these skills to ace Quality Assurance Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality assurance and auditing, particularly in the medical device sector. Emphasise your familiarity with FDA regulations and ISO standards, as these are crucial for the role.
Craft a Compelling Cover Letter: In your cover letter, express your passion for quality management and how your background aligns with the company's mission of improving lives through advanced transplant technology. Mention specific experiences that demonstrate your attention to detail and analytical skills.
Highlight Relevant Skills: Clearly outline your skills related to internal auditing, risk assessment, and process improvement. Use examples from your past work to illustrate how you've successfully identified areas for improvement and implemented corrective actions.
Proofread Your Application: Before submitting, carefully proofread your application materials for any spelling or grammatical errors. A polished application reflects your attention to detail, which is essential for a Quality Assurance Specialist.
How to prepare for a job interview at Skills Alliance
✨Know Your Regulations
Familiarise yourself with key regulations such as FDA 21 CFR Part 820, ISO 13485, and EU MDR. Being able to discuss these standards confidently will demonstrate your expertise and commitment to quality assurance.
✨Showcase Your Audit Experience
Prepare specific examples from your past auditing experiences that highlight your attention to detail and ability to identify areas for improvement. This will help illustrate your value as a Quality Assurance Specialist.
✨Demonstrate Analytical Skills
Be ready to discuss how you've used analytical skills to evaluate processes and propose corrective actions. Providing concrete examples of how you've improved quality systems in the past can set you apart.
✨Engage with Emotional Intelligence
During the interview, showcase your emotional intelligence by demonstrating how you handle interactions with stakeholders. Discussing your approach to maintaining positive engagement during audits will reflect well on your professional demeanor.
