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Salary not available. View on company website.
Cyden Ltd, Abertawe
- Onsite working
- Full time
- Permanent
Posted 3 days ago, 25 Apr
Job ref: 8c470a0d26aa44a6beec3b37531c587d
Full Job Description
- 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 identified
- Monitoring follow-up actions and conducting verification of effectiveness audits
- Conducting regulatory compliance checks
- Supporting Third Party regulatory audits and customer audits
- Completion of compliance checks against ISO 13485, MDSAP and EU MDR for:
- NPI/ECN's
- Customer complaints
- CAPA
- Concessions 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 Desirable Knowledge/experience of NPI/ECN/CAPA/Concession processes Qualifications and training: Essential ISO 13485 Desirable Regulatory requirements training MDSAP/ EU MDR Internal Auditing
· 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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