Under the direction of the Operations Manager, conduct and provides technical leadership towards the identification of the causes for non-conformances and process, failures and for the implementation of the remedial, corrective and preventive actions
Job Summary
Under the direction of the Operations Manager, conduct and provides technical leadership towards the identification of the causes for non-conformances and process, failures and for the implementation of the remedial, corrective and preventive actions.
Responsible for overseeing the Non Conformance Report (NRs) and Corrective action and preventive action (CAPA) and Audit Observations.
Provide guidance to manufacturing supervisors to ensure that effective in-depth investigations are performed.
Matching Summary
Under the direction of the Operations Manager, conduct and provides technical leadership towards the identification of the causes for non-conformances and process, failures and for the implementation of the remedial, corrective and preventive actions.
Skills & Requirements
Must-have
Non-conformance investigations
CAPA implementation
Quality trends analysis
FDA 21 CFR compliance
ISO 13485 knowledge
Applied statistics
Failure mode analysis
Nice-to-have
Leadership and guidance
Cross-functional team collaboration
Process enhancement direction
Assertiveness and creativity
Technologically savvy
Key Requirements
Bachelors Degree required
Minimum 4 years experience in NC/CAPA & Audits Observations