Join to apply for the Quality Compliance Engineer role at CyDen.
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.
* Completing compliance checks against ISO 13485, MDSAP, and EU MDR for:
o NPI/ECN's
o Customer complaints
o CAPA
o Concessions
Experience:
* Essential: Auditing Experience to ISO 13485/MDSAP/EU MDR.
* Knowledge of MDSAP/EU MDR Regulatory requirements.
* Desirable: Knowledge/experience of NPI/ECN/CAPA/Concession processes.
Qualifications and training:
* Essential: ISO 13485 certification.
* Desirable: Regulatory requirements training, MDSAP/EU MDR Internal Auditing.
Other attributes:
* Great attention to detail.
* Resilience/Tenacity.
* Good communication skills (verbal & written).
* Ability to work with minimal supervision.
In return, we offer competitive pay, 25 days holiday plus Bank holidays (rising to 30 with service), 5% pension contributions, sick pay, career development, Employee Assistance Programme, and Cycle to Work Scheme.
Additional information:
* Seniority level: Not Applicable
* Employment type: Full-time
* Job function: Management and Manufacturing
* Industries: Consumer Goods
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