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 is 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 in Wales employer: Yolk Recruitment Ltd
Join a leading manufacturing business that prioritises quality and compliance in the medical device sector. As a Quality Compliance Engineer, you'll be part of a stable and collaborative team that values continuous improvement and offers opportunities for professional growth. Enjoy competitive salary packages, flexible working hours, and a comprehensive healthcare scheme, all while making a meaningful impact in a highly regulated environment.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Compliance Engineer in Wales
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like Yolk Recruitment Ltd looking for candidates who are engaged and informed.
We think you need these skills to ace Quality Compliance Engineer in Wales
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at Yolk Recruitment Ltd. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at Yolk Recruitment Ltd
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with Yolk Recruitment Ltd’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
