At a Glance
- Tasks: Conduct internal audits and ensure compliance with quality standards in a regulated 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-quality standards and influence compliance across the business.
- Qualifications: Experience in internal auditing and strong knowledge of ISO 13485, MDSAP, and EU MDR.
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 will 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 in Briton Ferry employer: Yolk Recruitment
Join a leading manufacturing business that prioritises quality and continuous improvement, offering a collaborative work culture 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 in a regulated medical device environment while enjoying a supportive team atmosphere.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Compliance Engineer in Briton Ferry
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry and let them know you're on the hunt for a Quality Compliance Engineer 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 ISO 13485, GMP, and MDSAP regulations. Be ready to discuss how your experience aligns with the responsibilities of maintaining a robust Quality Management System. Confidence is key!
✨Tip Number 3
Showcase your auditing skills! Bring examples of past audits you've conducted and how you tackled non-conformances. This will demonstrate your proactive approach and ability to influence compliance standards effectively.
✨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 genuinely interested in joining our collaborative team focused on quality and continuous improvement.
We think you need these skills to ace Quality Compliance Engineer in Briton Ferry
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your experience with ISO 13485, GMP, and any relevant auditing roles. We want to see how your background aligns with the Quality Compliance Engineer position, so don’t be shy about showcasing your skills!
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. We love seeing candidates who are proactive and confident in their abilities.
Showcase Your Achievements:When detailing your past experiences, focus on specific achievements related to internal audits and compliance standards. We appreciate numbers and results, so if you improved a process or reduced non-conformances, let us know!
Apply Through Our Website:We encourage you to apply directly through our website for a smoother application process. It helps us keep everything organised and ensures your application gets the attention it deserves!
How to prepare for a job interview at Yolk Recruitment
✨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 of your internal auditing experience. Think about challenges you've faced, how you identified non-conformances, and the corrective actions you implemented. This will help you demonstrate your problem-solving skills and proactive approach.
✨Collaborate and Communicate
Since this role involves working closely with senior stakeholders, practice articulating how you’ve successfully collaborated with teams in the past. Highlight your communication skills and how they contributed to continuous improvement in quality compliance.
✨Show Your Passion for Quality
Express your enthusiasm for maintaining and improving quality management systems. Share your thoughts on why quality is important in the medical device industry and how you stay updated on best practices and regulatory changes.
