About this role
The incumbent provides direction and supervises the Quality Improvement (Design) and technical work unit team to ensure Quality Systems Improvement Strategies are implemented following compliance with Laws & Regulations. Manages work unit direct report people recruitment, attendance, leave of absences, performance management / monitoring. Incumbent decisions are based on functional area objectives and company policies and procedures. Also, provide advice and recommend changes to operational policies. Manage and execute the support to the ECO process to ensure the involvement of appropriate SME’s. Will act as the focal point of contact for all change leaders including R&D SME’s.
Qualifications
Knowledge, Skills and Abilities:
- Broad knowledge in Quality Systems regulations in the medical device / pharmaceutical industry.
- Thorough knowledge of project management
- Strong background in Change Control and Risk Management process
- Experience with metrology equipment
- Exposure to clinical studies requirements
- Knowledge on statistical analysis tools
- Proven Leadership skills
- High analytical capacity and level of professionalism and judgment to resolve problems
- Excellent oral/ technical written communication skills
- Fully bilingual
Experience:
- Six or more years of experience in Quality Engineering, preferably in Medical Device Industry
- Two (2) years of experience leading Quality or Technical Team.
Education:
- Bachelor’s degree in Sciences (Chemistry / Biology / Engineering)
- Service oriented
- Strategic thinking to drive solutions
- High degree of Innovation
- Proven knowledge in computer Microsoft (Excel, Word, PowerPoint) application and Quality Documentation Systems