Job Description
Quality Compliance EngineerYolk 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 requirementsConduct internal audits and produce clear, detailed audit reports with identified non-conformances and corrective actionsTrack, 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 activitiesCarry out ongoing regulatory compliance assessments across quality systems and processesSupport external audits including third-party certification bodies, regulatory authorities, and customer auditsWork collaboratively with wider Quality and Operations teams to ensure continuous improvement of compliance standardsContribute to maintaining and improving documentation and audit trails within the Quality Management SystemEnsure compliance checks are completed across key quality processes including:New Product Introduction (NPI) / Engineering Change Controls (ECN)Customer complaints handling processesCAPA systems and investigationsProduct concessions and deviationsThis is what you'll need:Proven experience in internal auditing within a regulated industryStrong working knowledge of ISO 13485 Quality Management SystemsExperience 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 salaryFlexitime optionHealth care schemeAnnual bonusTPBN1_UKTJ