We are seeking a Quality Assurance Specialist to join our team in a dynamic, multinational medical device manufacturing company based in Ireland.
The role is a 12-month contract with the opportunity for career advancement and flexibility to work with different teams within other manufacturing units.
Purpose of Job:
As a Quality Assurance Specialist, you will be responsible for initiating and performing defined quality activities leading to new or improved processes or systems. This includes but is not limited to ensuring compliance is maintained for product manufacturing, packaging, and labeling, developing a strategy, implementing appropriate sampling methods, writing up and reviewing CAPAs, NC/NCMRs and SCARs to address compliance issues, and providing guidance to suppliers and engineering.
Key Responsibilities:
* Reviewing and approving change controls.
* Maintaining compliance with regulatory bodies such as ISO and FDA.
* Developing and implementing quality strategies.
* Ensuring adherence to Environmental, Health and Safety (EHS) Policies.
* Following strict adherence to the requirements of CGMP.
Required Skills and Qualifications:
Degree level qualification in Quality, Science or Engineering is required. A minimum of three years experience working in regulated environments specifically medical device, FDA or ISO 13485 registered work environments is preferable. Strong computer skills including MS Excel, PowerPoint, and Word are essential.
Benefits:
* A global medical device company offering a hybrid working model.
* Career advancement opportunities.
* Flexibility to work with different teams within other manufacturing units.