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Quality Systems Engineer II
Quality Systems Engineer II role , maternity cover contract with a leading medical devices company based in South Tipperary.
THe overall purpose of this role is to :
- Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, 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.
- Level 8 qualification and 2 to 4 years relevant work experience
- 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.
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