Operations Quality Assurance Manager

A global medical technology company focused on women's health is looking an Operations Quality Assurance Manager.

Objective:

• Plan, organize, supervise, and control quality assurance activities across the manufacturing and distribution processes intended to meet internal and external customers, intended to ensure full compliance to applicable regulations and quality system requirements, and intended to boost continuous improvement. When required, assist other functional areas of the organization.

Requirements:

• Bachelor’s degree in Engineering, Business Administration, or Science, or equivalence experience.
• Experience in manufacturing and supply distribution processes is a must
• Experience of at least seven years in the Medical Devices industry. A minimum of five years of experience in managerial positions in Quality functional areas.
• Knowledge of ISO 9001, ISO 13485, FDA CFR Part 820, European MDD/MDR, and/or GxPs.
• Knowledge and ability to communicate in English by speaking and writing. Technical writing skills to prepare reports and to review/approve reports of others. Ability to read and understand technical documents associated with the industry.
• Experience in use of SAP S/4 HANA (preferred).
• Schedule: Monday to Friday from 6am to 3pm