Quality Assurance Specialist

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
• Reporting
• Detail oriented

Education Requirements:

• 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