Our partner is a producer of high-quality Medical Devices with multiple production locations in Europe and in North America and a worldwide distribution network, are looking for a new colleague.
- Support and coordinate EDC processes and make sure they meet all regulatory compliance requiremnts and are in line with QA procedures;
- Advice and provide direction to sustain and approve the Quality System standards for the facility and employee training programs to help ensure regulatory compliance;
- Interact with sources of supply regarding product quality complaints.
- Participate as needed in regulatory audits to ensure compliance with FDA and ISO regulations;
- Maintain appropriate operating procedures and policies within corporate guidelines;
- Perform, coordinate and follow up on internal audits;
- Administer and initiate training activities in LMS;
- Perform Country Specific audits and product inspection reviews per approved procedures;
- Train Associates;
- Assist Supervisors in maintaining department standards in QA;
- Interact with sources of supply regarding product quality complaints and coordinate related RGA’s, IDO’s and rework activities;
- Facilitate and coordinate any CAPAs required for the RO facility;
- Participate on project teams to represent quality systems as needed;
- Facilitate and coordinate any Non-Conformance Concessions required for the RO facility;
- To perform other job related duties as determined and assigned by management.
- Knowledge of Lean & Six Sigma preferred;
- Min. 2 years operating experience (knowledge of SAP/ERP system);
- Degree/technical education;
- Ability to process document change requests and all Document control requirements on Qumas and understanding of applicable ISO13485 requirements;
- Excellent communication skills;
- Detail oriented.