Performs business quality system audits – includes audit preparation, conducting audits, writing audit reports, communicating findings to suppliers, business, and stakeholders, and audit follow-up.
Continuously improves the effectiveness of existing quality systems and processes by converting quality system related deficiencies identified through audit findings into improved system and process practices.
Reviews and approves corrective action plans and actions as a result of audit findings.
Effectively executes and/or follows-up on CAPA (Corrective and Preventive Action) Quality System non-conformance or improvements. Performs all activities in full compliance with the quality policies and procedures.
Makes decisions with some level of oversight.
Verifies closure of corrective actions and preventive actions from audits.
Determines statistical sampling of documents and records to be reviewed during audits.
Prepares audit trend reports.
Supports sites, affiliates, departments, and areas across the client to sustain compliance against applicable standards and regulations.
- ISO-13485:2016, MDSAO 2016, FDA certified
- ASQ Bio Medical Certification
- Heavy on Process audits
- SAO/ERP ( ETQ)
Source: Job Diva – Job Listing