Want to join a new operation setup?
We are currently looking for an experienced and highly motivated QA/RA Manager. This position will be responsible for managing all QA /QC and RA activities to develop the company's growth in Europe. Our clients are a global leader in developing and manufacturing healthcare medical device products and are suppliers to over 80 countries worldwide with their products. They are still expanding their European base and have recently up a small manufacturing facility here in Ireland, located in North Dublin.
You will be starting within a small start-up facility environment so they are seeking a candidate who has ideally come from a small/medium-sized factory manufacturing environment who is hands-on in all aspects of QA/RA aspects and will be the quality function until they expand and develop a team. They are seeking a candidate at the Supervisor level who will have a career step up into a management role and be given global support from the Head office and other sites.
Duties and Responsibilities
- Responsible for RA activities including product registration, compliance audits preparation and responding.
- Be accountable for complaints, recall issues and carrying out the investigation.
- Ensure to complete the documentation and activities of CAPA on time.
- Oversee the compliance of document and data control systems.
- Manage the execution of internal and external audits and ensure timely closure.
- Implement an effective operator training and certification program. Also, manage the conduct of QMS training.
- Lead improvement activity and Total Quality Control activities of the organization to success.
- Plan and manage the annual budget.
- Bachelor’s degree in science, engineering or related field (Licensed pharmacist a distinct advantage).
- 3+ years of management experience required or Supervisory level
- 5-7 years’ experience in a manufacturing set-up, particularly in the medical device manufacturing company.
- English business level speaker.
- Strong knowledge of Iso 13485, FDA regulations, and other local and international regulatory requirements.
- Excellent decision-making skills, strong leadership, and communication proficiency.
Our clients are seeking a candidate who is seeking a career step up into a manager role. We are seeking to speak with candidates who are in the supervisory or senior specialist level and have some management/ and or supervisory experience and or mid-level managers seeking a new opportunity to join a start-up manufacturing facility with support from a global team.
FULL SPEC ON APPLICATION**
For a confidential discussion and more information on the role, please contact Tina Cornally.