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- Tasks: Conduct audits and ensure compliance with quality standards in medical device manufacturing.
- Company: Join a leading medical devices company focused on innovation and quality.
- Benefits: Enjoy a salary of £40,000 p.a., excellent benefits, and training opportunities.
- Why this job: Be part of a mission-driven team that enhances lives through quality products.
- Qualifications: Experience as a Quality Auditor in medical devices and knowledge of ISO 13485 required.
- Other info: Flexible working options with occasional office visits and travel across the UK.
The predicted salary is between 32000 - 48000 £ per year.
Owen Daniels are supporting a Leading Medical Business based in Wolverhampton (Covering the UK) in recruiting for a Lead Auditor to join the team on a permanent basis.
Salary: £40,000 p.a. + Excellent Benefits + Training.
Leading medical devices manufacturing company dedicated to innovation, safety, and quality with the mission to produce life-enhancing products that meet the highest regulatory and industry standards. As they continue to grow, they are seeking a meticulous and detail-oriented Quality Auditor to join the team.
Job Overview:
The Quality Auditor will be responsible for ensuring compliance with internal quality processes, regulatory requirements, and industry standards. You will conduct audits, identify areas for improvement, and work closely with cross-functional teams to maintain the highest quality standards in our production processes.
Key Responsibilities:
- Conduct internal audits of manufacturing processes, documentation, and quality control systems to ensure compliance with ISO 13485, FDA regulations, and other applicable standards.
- Prepare and maintain audit reports, documenting findings, non-conformances, and corrective actions.
- Work with quality and production teams to implement corrective and preventive actions (CAPAs) and ensure continuous improvement.
- Assist in external audits conducted by regulatory bodies and customers.
- Ensure that all employees adhere to Good Manufacturing Practices (GMP) and company policies.
- Provide training and support to teams on quality systems and regulatory requirements.
- Stay updated on industry regulations, changes in compliance requirements, and best practices.
Qualifications & Experience:
- Proven experience as a Quality Auditor in a medical devices manufacturing environment.
- Strong knowledge of ISO 13485, FDA regulations, and GMP.
- Experience conducting internal and external audits.
- Excellent analytical skills with attention to detail.
- Strong communication and reporting skills.
- Certification in auditing (e.g., Lead Auditor qualification) is a plus.
- Ability to work collaboratively and independently in a fast-paced environment.
Fantastic role which covers the UK, mix of home working or based at clients with travel into the office 1-2 per week if not needed with clients.
Please click apply now to be considered.
Quality Lead Auditor employer: Owen Daniels
Contact Detail:
Owen Daniels Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Lead Auditor
✨Tip Number 1
Familiarise yourself with ISO 13485 and FDA regulations. Understanding these standards inside out will not only help you in interviews but also demonstrate your commitment to quality assurance in the medical devices sector.
✨Tip Number 2
Network with professionals in the medical devices industry. Attend relevant conferences or webinars, and connect with current employees at the company on LinkedIn. This can provide insights into the company culture and potentially give you a referral.
✨Tip Number 3
Prepare for scenario-based questions during the interview. Think of specific examples from your past experience where you successfully conducted audits or implemented corrective actions, as this will showcase your practical knowledge and problem-solving skills.
✨Tip Number 4
Stay updated on the latest trends and changes in quality assurance within the medical devices field. Being knowledgeable about recent developments can set you apart and show your passion for continuous improvement in quality management.
We think you need these skills to ace Quality Lead Auditor
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the Quality Lead Auditor position. Understand the key responsibilities and qualifications required, as this will help you tailor your application.
Tailor Your CV: Customise your CV to highlight relevant experience in quality auditing, particularly in the medical devices sector. Emphasise your knowledge of ISO 13485, FDA regulations, and any auditing certifications you hold.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance and your attention to detail. Mention specific examples of how you've successfully conducted audits or implemented corrective actions in previous roles.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your professionalism and attention to detail, which are crucial for a Quality Lead Auditor.
How to prepare for a job interview at Owen Daniels
✨Know Your Standards
Familiarise yourself with ISO 13485, FDA regulations, and GMP before the interview. Being able to discuss these standards confidently will show your expertise and commitment to quality.
✨Prepare for Scenario Questions
Expect questions that ask you to describe how you've handled audits or compliance issues in the past. Prepare specific examples that highlight your analytical skills and attention to detail.
✨Showcase Your Communication Skills
As a Quality Lead Auditor, you'll need to communicate findings effectively. Practice explaining complex concepts clearly and concisely, as this will be crucial during the interview.
✨Demonstrate Continuous Improvement Mindset
Be ready to discuss how you've contributed to continuous improvement in previous roles. Highlight any corrective actions you've implemented and the positive outcomes that followed.
