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 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
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.