The position of QA will join a dynamic and global leading company in the medical device space, which includes two strong global brands in the space of Ostomy; Continence Care; and Critical Care. Striving for a dynamic Culture of Quality to continuously improve product production.
Responsibilities:
- Oversee the QA department and staff as far as development, training and onboarding.
- Develop and maintain strategies for the QA function and communicating with key. stakeholders.
- Develop and implement the QMS.
- Implementation of internal and external Audits.
- Oversee complaints, risk management, notified bodies and change control.
- Oversee the introduction of new products, changes to existing products and innovation.
- Support the QA operating budget in conjunction with the facility manager.
- Oversee finished goods product release, including returns handling.
- Decision making authority in relation to product quality in conjunction with stakeholders.
Requirements:
- Bachelor degree in Quality/Science or Engineering
- 5+ years experience in Medical device/Pharma industry in Quality positions including Quality system leadership.
- Experience with ISO13485, 14971, FDA, MMD/MMR
- Demonstrated knowledge of problem solving and implementing continuous improvement
- Demonstrated ability to manage/lead a team.
- Excellent communication skills, written and verbal
- Fluent English
