Quality Compliance Specialist - Medical Devices
Posted on Aug 18, 2021 by Michael Bailey Associates - Zurich
We have a new exciting opportunity for QA specialist, who will be responsible for effective compliance programs and identification and alerting of quality issues in time to resolve potential adverse effects.
Principal Duties & Responsibilities
* Schedule and conduct internal audits
* Partner with external manufacturer to ensure effective inspection readiness
* Partner with Source Quality to support Quality Programs
* Provide data and present compliance information during Joint Quality Review
* Monitor, analyze and report of compliance data
* Share and facilitate implementation of Proactive Compliance Strategies
* Lead/influence discussions with Regulators
* Alert organization to existing and potential problems and risks & Support Remediation Programs
* Collaborate with functional department to establish effective corrective and preventive actions
* Accountable for proactive partnership and completion of Supplier Audit Follow Up.
* Communicate, educate and facilitate implementation of changes to external Standards and Regulation across external manufacturer sites
* Support supplier external audit response development
* Assist in formulating regulatory policies and procedures to be followed by company personnel and external manufacturer.
* University/Bachelor Degree or Equivalent is required
* Requires five (5+) years of related experience in areas such as Quality Operations, Compliance, Supplier Quality, Quality Systems, Regulatory etc.
* Experience supporting External Health Authority and Regulatory Body Inspection is required,
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.