As QMS Compliance Engineer you will be responsible for driving and supporting CT/AMI QMS compliance to international medical device regulations, ISO13485, and general quality system requirements. Additionally, you will be responsible for managing and monitoring CAPA activities.
Your role:
Ensure readiness for External Audits.
Support of the execution of external audits, internal audits and inspections including FDA, Notified Body and other 3rd party audits in CT/AMI.
Execution of internal quality audits.
Assists organizational units in addressing compliance deficiencies.
Global facilitation of the CAPA process per all relevant procedures.
Be the center of knowledge for all the CAPA practices and the Trackwise tool.
Support and present CAPA during internal and external audits successfully.
Provide other compliance support, including reviewing audit reports, including correct findings classification, and responses to audit findings for completeness and effectiveness and providing training on key compliance topics.
Support tracking and monitoring of audit finding action plans until closure, including assistance in the resolution to closure.
Support tracking and monitor key performance indicators (KPIs) and implement corrective actions as required.
Perform analyses and continuous monitoring in support of internal audits, management reviews, and external audits.
Supports the implementation of the Business long-range quality, regulatory and compliance policy. Supports managing plans for all QMS parts in scope while maintaining compliance and effectiveness throughout the duration of transitions.
Requirements: You're the right fit if you have:
Bachelor of Science or equivalent in technical/ engineering or clinical field.
At least 3 years professional work experience with medical device regulations and standards (such as, US FDA QSR, EU MDD, Canadian CMDCAS, Japan PAL regulation and other WW regulations and standards).
Fluent verbal and written English.
Good communication skills and convinced team player.
Attention to detail and self-directed.
This position is open to all candidates.