Quality Assurance Associate (M/F/D)

Position Summary:

• Support quality initiatives and be an advocate for quality throughout the company
• Maintain electronic Quality Management System
• Respond to daily quality issues including representing Quality in various meetings
• Assist in leading initiatives and maintaining quality systems in accordance with applicable regulatory standards (i.e., ISO, CAP/CLIA, GxP)
• Assist in preparation for and hosting client audits and annual surveillance audits
• Collaborate with colleagues to audit, identify and correct quality issues and improve internal processes
• Develop procedures, job-aids and other controlled documents
• Perform trend reporting of non-conformances, supplier issues and customer complaints etc. to track KPIs and flag quality concerns to be presented to department managers and executives
• Review and support investigations/CAPAs of non-conformances, supplier issues and customer complaints and recommend corrective actions
• Support to departments during implementation of quality tasks.Educate employees on Quality Management System through training and presentations
• Respect the privacy of the personal information of patients, co-workers, and all individuals with whom the Company interacts
• Ensure compliance with all laws and regulations applicable to the Company and its operations
• Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
• Consistent and predictable availability during our normal business hours is an essential function of the position.

Education Requirements:

• Bachelor’s degree preferred, with major in life sciences desirable
• Apprenticeship in natural science (Technical Assistant or an equivalent qualification) will be considered

Qualification/Experience:

• At least two years’ professional work experience, preferably in the Quality Management field
• Experience supporting a business is preferred.
• Experience with internal and external audit processes preferred
• Excellent computer skills, including Microsoft Excel, Word and PowerPoint
• Strong attention to detail with excellent organizational skills and the ability to prioritize multiple tasks
• The incumbent must show effective communication skills and ability to collaborate.
• Able to work independently as well as in an in-person and virtual team setting
• Excellent English verbal and written communication skills