At a Glance
- Tasks: Conduct internal audits and ensure compliance in a regulated medical device environment.
- Company: Leading manufacturing business prioritising quality and continuous improvement.
- Benefits: Competitive salary, flexitime, health care scheme, and annual bonus.
- Other info: Join a stable, collaborative team where quality is a top priority.
- Why this job: Play a key role in maintaining high compliance standards and influence quality across the business.
- Qualifications: Experience in internal auditing and strong knowledge of ISO 13485 and regulatory compliance.
The predicted salary is between 40000 - 50000 £ per year.
Yolk Recruitment are supporting a leading manufacturing business with the recruitment of a Quality Compliance Engineer to join their established Quality team. This is a fantastic opportunity for an experienced quality professional with strong internal auditing and regulatory compliance experience to play a key role in maintaining and improving a robust Quality Management System within a regulated medical device environment.
This role offers genuine scope to take ownership of internal audit programmes and influence compliance standards across the business, working closely with senior stakeholders in a highly regulated environment. You'll be joining a stable and collaborative team where quality is a top priority and continuous improvement is actively encouraged.
This role is ideal for someone who is confident working independently, proactive in approach, and experienced in ISO 13485, GMP, MDSAP and EU MDR compliance, with a strong background in auditing and quality systems within a regulated industry.
Key responsibilities:- Deliver and maintain the internal audit schedule in line with ISO 13485 Quality Management System and GMP requirements
- Conduct internal audits and produce clear, detailed audit reports with identified non-conformances and corrective actions
- Track, monitor and verify the effectiveness of corrective and preventative actions (CAPA follow-up and closure)
- Provide support in maintaining readiness for regulatory inspections and audit activities
- Carry out ongoing regulatory compliance assessments across quality systems and processes
- Support external audits including third-party certification bodies, regulatory authorities, and customer audits
- Work collaboratively with wider Quality and Operations teams to ensure continuous improvement of compliance standards
- Contribute to maintaining and improving documentation and audit trails within the Quality Management System
- Ensure compliance checks are completed across key quality processes including: New Product Introduction (NPI) / Engineering Change Controls (ECN), Customer complaints handling processes, CAPA systems and investigations, Product concessions and deviations
- Proven experience in internal auditing within a regulated industry
- Strong working knowledge of ISO 13485 Quality Management Systems
- Experience or working knowledge of MDSAP and/or EU MDR regulations (at least two of ISO 13485, MDSAP, EU MDR preferred)
- Competitive salary
- Flexitime option
- Health care scheme
- Annual bonus
Quality Compliance Engineer employer: Yolk Recruitment Limited
Join a leading manufacturing business that prioritises quality and continuous improvement, offering a collaborative work environment where your expertise as a Quality Compliance Engineer will be valued. With competitive salaries, flexible working options, and a strong focus on employee growth, this role provides an excellent opportunity to influence compliance standards while working closely with senior stakeholders in a regulated medical device setting.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Compliance Engineer
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that Quality Compliance Engineer role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO 13485, GMP, and MDSAP regulations. We recommend creating a list of common interview questions related to quality compliance and practising your responses. This way, you’ll feel confident and ready to impress!
✨Tip Number 3
Showcase your auditing experience! When you get the chance to chat with potential employers, highlight specific examples of how you've improved compliance standards or tackled non-conformances. We want to see your proactive approach 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’re always looking for passionate individuals who are eager to contribute to our quality team. Let’s make it happen together!
We think you need these skills to ace Quality Compliance Engineer
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Compliance Engineer role. Highlight your experience with ISO 13485, GMP, and any relevant auditing experience. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality compliance and how you can contribute to our team. Be sure to mention specific experiences that relate to the job description.
Showcase Your Achievements:When detailing your past roles, focus on your achievements rather than just responsibilities. We love to see how you've made an impact in previous positions, especially in maintaining or improving quality systems.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at Yolk Recruitment Limited
✨Know Your Standards
Make sure you brush up on ISO 13485, GMP, MDSAP, and EU MDR regulations before the interview. Being able to discuss these standards confidently will show that you're not just familiar with them, but that you can apply them in a practical setting.
✨Audit Your Experience
Prepare specific examples from your past roles where you've conducted internal audits or managed compliance processes. Use the STAR method (Situation, Task, Action, Result) to structure your answers, making it easy for the interviewer to see your impact.
✨Show Your Collaborative Spirit
Since this role involves working closely with senior stakeholders and various teams, be ready to discuss how you've successfully collaborated in the past. Highlight any experiences where you’ve contributed to continuous improvement initiatives or resolved compliance issues as part of a team.
✨Be Proactive About Questions
Prepare thoughtful questions about the company's quality management system and their approach to regulatory compliance. This not only shows your interest in the role but also demonstrates your proactive mindset, which is crucial for a Quality Compliance Engineer.
