Quality Compliance Engineer

Overall job purpose:

Internal auditing of the Quality Management System & completing compliance checks.

Key Responsibilities:

• Adherence to audit schedules for Cyden’s Quality Management System and Good Manufacturing Practices (GMP)
• Conducting audits on Cyden’s commercial partners
• Issuing audit reports and notifications on any follow-up actions identified
• Monitoring follow-up actions and conducting verification of effectiveness audits
• Conducting Device Compliance Audits
• 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 Internal Auditing

Desirable

·  MDSAP Fundamentals/Readiness

·   EU MDR Requirements

·   Formal engineering qualifications

Other attributes:

·       Great attention to detail

·       Resilience/ Tenacity

·       Good communication skills (verbal & written)

·       Completer/Finisher

·       Ability to work with minimal supervision