Quality Assurance Specialist
Generic for the role:
- 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 as needed in regulatory audits to ensure compliance with FDA and ISO regulations.
- 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
Essential Functions of the Role:
- Excellent communication skills
- Ability to interface with a computer for long periods of time
- Frequent walking throughout the facility
- Hands on attitude
- Detail oriented
- Minimum of a HBO work and thinking level
Specialized Skills/Technical Knowledge:
- Degree/technical education
- Knowledge of SAP/ERP system (min 2 years operating experience)
- Ability to process document change requests and all Document control requirements on Qumas and understanding of applicable ISO 13485 requirements.
- Auditor Training
- Knowledge of Lean & Six Sigma preferred
- Basic technical writing skills required
- Proficient computer skills, incl. MS office suite