Quality Compliance Engineer

Description:

Quality Compliance Engineer

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 deviationsThis is what you'll need:

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)And this is what you'll get:

Competitive salary
Flexitime option
Health care scheme
Annual bonus