QA Compliance Specialist

Department: Quality
Reports to: QC Manager

Responsible for performing internal and external audits. Responsible for performing quality review of complaints, CAPA, deviation, non-conformance and batch records. Provide support of daily operations by performing line clearance and checks.

* Perform internal audits and serve as lead auditor when appropriate. * Perform and schedule supplier audits and oversee supplier performance from a quality point of view. Some travel will be required. * Maintain and review the Approved Supplier List including updating and reviewing performance of vendors. * Train new and existing personnel to perform internal audits. * Review batch records and certificates of analysis for accuracy and completion prior to final release of product. * Perform line clearance and checks. Troubleshoot and investigate quality issues. * Help maintain and implement the Quality System. * Review customer complaints, CAPA, Deviations, to include initial customer contact, investigation and finding resolution, and close out with customer. * Performs other related duties as assigned

* Minimum Bachelors Degree with 2 years industry experience and knowledge of GMP/ISO requirements, specifically ISO 13485 Medical Devices and ISO 9001-2000. * Experience auditing in a GMP/ISO environment * Requires proficiency in word processing, spreadsheets and databases * Ability to interact positively and professionally with customers *Good presentation, organization and communication skills