Our client, a medical device company in Clonmel is currently looking to recruit a Quality Systems Engineer for their site.
Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support.
- Demonstrate a primary commitment to patient safety and product quality.
- Responsible for the implementation, co-ordination and continuous review of the CAPA, Internal and Corporate Compliance programs in Boston Scientific Ireland Ltd.
- Has expertise in internal auditing techniques and is familiar with all regulatory requirements (e.g., FDA, ISO and MDD/MDR ).
- Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Drives changes in procedures and standards to facilitate work efficiency and to maintain quality.
- Familiar with the internal auditing system.
- Acts as a leader of quality, QSR and ISO/MDD/MDR standards within one’s own group, constantly promoting awareness of best industry practices, making appropriate decision on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions.
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Qualification & Experience:
Level 8 qualification and 2 to 4 years relevant work experience
For further information on this Quality Systems Engineer role in Tipperary please contact Bimi Felix on 086 8395533 / email@example.com
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