Overall job purpose:Internal auditing of the Quality Management System & completing regulatory compliance checks. Key Responsibilities: Adherence to audit schedules for Cyden’s Quality Management System and Good Manufacturing Practices (GMP)Issuing audit reports and notifications on any follow-up actions identifiedMonitoring follow-up actions and conducting verification of effectiveness auditsConducting regulatory compliance checksSupporting Third Party regulatory audits and customer auditsCompletion of compliance checks against ISO 13485, MDSAP and EU MDR for:NPI/ECN’sCustomer complaintsCAPAConcessions These tasks are not intended as an exhaustive list of the post holder’s duties. The post holder is expected to carry out any reasonable request as deemed appropriate by their Line Manager to support business needs. Specific responsibilities and authorities are defined in procedures relevant to the role. Experience: Essential· Auditing Experience to ISO 13485/MDSAP/EU MDR· MDSAP/ EU MDR Regulatory requirements knowledge DesirableKnowledge/experience of NPI/ECN/CAPA/Concession processes Qualifications and training:EssentialISO 13485DesirableRegulatory requirements trainingMDSAP/ EU MDR Internal Auditing Other attributes: · Great attention to detail· Resilience/ Tenacity· Good communication skills (verbal & written)· Completer/Finisher· Ability to work with minimal supervision In return we offer competitive rates of pay, 25 days holiday plus Bank holidays rising to 30 with length of service, 5% Company pension contributions, Company sick pay, career development opportunities, Employee Assistance Programme and Cycle to Work Scheme.CyDen is committed to being an equal opportunities employer and values diversity.
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