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- Tasks: Lead and execute audits to ensure compliance with medical device regulations.
- Company: Global leader in medical device innovation focused on improving patient outcomes.
- Benefits: Competitive salary, hybrid work model, and opportunities for professional growth.
- Why this job: Make a real impact in healthcare by ensuring quality and compliance.
- Qualifications: 5+ years in quality auditing, certified lead auditor in MDSAP/ISO 13485.
- Other info: Join a culture of quality and continuous improvement in a dynamic environment.
The predicted salary is between 36000 - 60000 £ per year.
Job Title: Senior / Lead Auditor
Location: Oxford, Hybrid
Job Type: Permanent Full Time
A global leader in medical device innovation, dedicated to advancing transplant technology and improving patient outcomes, is seeking a highly skilled Senior Auditor – Quality Management Systems (QMS). This senior-level role is responsible for planning and executing a full spectrum of audits: internal, external, and supplier across global sites. The Senior Auditor ensures compliance with international medical device regulations, company standards, and the Quality Management System (QMS), while also driving continuous improvement initiatives. The successful candidate will be an experienced, certified auditor with deep knowledge of global medical device regulations, including FDA, EU MDR, and MDSAP.
Responsibilities
- Plan, lead, and execute internal, external, and supplier audits across international operations.
- Ensure compliance with FDA 21 CFR Part 820, ISO 13485, EU MDR, MDSAP, and other applicable regulatory frameworks.
- Evaluate processes against quality standards, identifying risks, gaps, and opportunities for improvement.
- Perform risk-based audit assessments, analyze findings, and identify systemic or recurring issues.
- Develop, communicate, and present clear and comprehensive audit reports to senior leadership and stakeholders.
- Collaborate with internal teams and external partners to develop and verify the effectiveness of corrective and preventive action (CAPA) plans.
- Provide expert training and guidance on QMS requirements, audit readiness, and regulatory expectations.
- Monitor regulatory updates and proactively integrate changes into the QMS audit program.
- Uphold the company’s Code of Conduct and foster a culture of quality, compliance, and continuous improvement.
Requirements:
- Bachelor’s degree in a scientific, engineering, quality, or regulatory discipline (or equivalent experience).
- Minimum of 5 years of experience in quality auditing within the medical device industry, including supplier audit management.
- Certified lead auditor with recognized qualifications in MDSAP and/or ISO 13485 (required).
- Strong working knowledge of global medical device regulations, including FDA QSR, EU MDR, ISO 14971, and CMDR.
- Demonstrated success leading internal, external, and supplier audits across diverse geographies.
- Excellent communication and interpersonal skills with the ability to influence and engage stakeholders at all levels.
- High emotional intelligence and professionalism, ensuring positive and constructive engagement with auditees.
- Strong analytical, problem-solving, and organizational skills, with a focus on driving sustainable improvements.
- Proficiency in Microsoft Office Suite (Excel, PowerPoint, Visio, Word, Access).
- Experience managing complex audit programs; additional certifications (e.g., MDR auditor qualification) are a strong asset.
Please reach out to emily.james@skillsalliance.com for further information.
Senior Auditor employer: Skills Alliance
Contact Detail:
Skills Alliance Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Auditor
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device industry and let them know you're on the lookout for a Senior Auditor role. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of FDA regulations and ISO standards. Be ready to discuss how you've tackled compliance challenges in the past. We want to see your expertise shine through!
✨Tip Number 3
Showcase your audit experience with real-life examples during interviews. Talk about specific audits you've led, the outcomes, and how you drove improvements. This will help us see your impact in action!
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Senior Auditor
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Auditor role. Highlight your experience with quality management systems and any relevant certifications. We want to see how your skills align with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about medical device innovation and how your background makes you the perfect fit for our team. Let us know what drives you!
Showcase Your Audit Experience: Be specific about your audit experience in the medical device industry. Mention any international audits you've led and the regulations you're familiar with. We love seeing concrete examples of your expertise!
Apply Through Our Website: Don't forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. We can’t wait to see what you bring to the table!
How to prepare for a job interview at Skills Alliance
✨Know Your Regulations
Make sure you brush up on the key regulations like FDA QSR, EU MDR, and ISO 13485. Being able to discuss these confidently will show that you’re not just familiar with them but can apply them in real-world scenarios.
✨Prepare for Scenario Questions
Expect questions about how you've handled audits in the past. Think of specific examples where you identified risks or implemented improvements. Use the STAR method (Situation, Task, Action, Result) to structure your answers.
✨Showcase Your Communication Skills
As a Senior Auditor, you'll need to communicate findings effectively. Practice explaining complex audit results in simple terms. This will demonstrate your ability to engage stakeholders and present clear reports.
✨Demonstrate Continuous Improvement Mindset
Be ready to discuss how you've driven continuous improvement initiatives in previous roles. Highlight any successful CAPA plans you've developed and how they positively impacted quality management systems.
