Social Network Login/Join
Internalauditing of the Quality Management System & completing regulatory compliance checks.
Key Responsibilities:
1. Adherence to audit schedules for Cyden's Quality Management System and Good Manufacturing Practices (GMP)
2. Issuing audit reports and notifications on follow-up actions
3. Monitoring follow-up actions and conducting verification of effectiveness audits
4. Conducting regulatory compliance checks
5. Supporting third-party regulatory audits and customer audits
6. Completing compliance checks against ISO 13485, MDSAP, and EU MDR for:
* NPI/ECN's
* Customer complaints
* CAPA
* Concessions
Note: These tasks are not exhaustive. The post holder is expected to perform any reasonable duties as assigned by their Line Manager to support business needs. Specific responsibilities and authorities are outlined in relevant procedures.
Experience:
* Auditing experience to ISO 13485, MDSAP, and EU MDR
* Knowledge of MDSAP/EU MDR regulatory requirements
* Experience with NPI/ECN/CAPA/Concession processes
Qualifications and Training:
* ISO 13485 certification
* Regulatory requirements training
* MDSAP/EU MDR internal auditing
Other Attributes:
* Great attention to detail
* Completer/Finisher mindset
* Ability to work independently
Benefits:
We offer competitive pay, 25 days holiday plus bank holidays (rising to 30 with service), 5% company pension contributions, sick pay, career development opportunities, Employee Assistance Programme, and Cycle to Work Scheme.
CyDen is committed to being an equal opportunity employer and values diversity.
#J-18808-Ljbffr