changing lives.
The primary responsibilities include, but are not limited to, the following areas: QMS documentation management, CAPA process support and execution according to standards by business stakeholders and performing audits.
In this role, you will…
- Ensure good documentation practices according to QMS.
- Identify, analyze, and lead the implementation of continuous improvement opportunities / projects in quality processes and tools, focused on exceeding customer needs and ensuring compliance with applicable standards and regulations.
- Participate and conduct in yearly internal audit schedules and supplier audit schedules .
- Be involved, as needed, in any global or outside audits.
- Coordinate and support business with CAPA (corrective and preventive actions) process.
- Give QMS and medical device regulations related training to the organization as needed.
In this role, you’ll need …
- MSc in LifeScience or Quality Engineering degree is desired;
- Certification as Internal Auditor for ISO 13485:2016 is a benefit;
- 5-6 year minimum experience working in Medical Device, Pharma or life science Quality Management position is required.
- Extensive Internal Auditor experience in performing internal quality audits.
- Experience in QMS development and implementation within manufacturing work environment, Medical Device Industry is an additional profit.
