Quality Systems Engineer II
This is a very exciting time to join a growing and evolving Internal Audit team with a large scope to reshape the team and how they operate in a changing environment. The role is diverse with a hands-on element of conducting audits along with a strategic role of shaping the function and partnering with the business.
What you will do:
- Demonstrate a primary commitment to patient safety and product quality
- Has expertise in internal auditing techniques and is familiar with all regulatory requirements (e.g., FDA, ISO and MDD)
- 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 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
What you will have:
- NFQ level 8 (240 credits) in Science, Quality or any other STEM discipline
- Minimum requirement 3-5 years in a Medical Device / Pharmaceutical environment, including practical experience of working within a highly regulated quality management system (QMS)
- Strong understanding and experience in the implementation of ISO 13485, ISO 14971, MDR
- Dynamic team player who will lead intra/inter-departmental teams and/or projects that support continuous improvement of the Quality Management System. Builds positive support and acts as role model for change
- May lead/support management of regulatory inspection activities such as readiness preparation, inspection management, and/or response management
- Leads intra or interdepartmental teams of an operational nature such as preparing the company for minor changes in regulations, continuous improvement initiatives
- Accredited lead auditor against recognised quality standards in support of internal audits
- Must be able to organise and prioritise tasks, must be detail orientated and self-motivated
- Strong influence management skills. Demonstrated ability to work cooperatively at all levels in a matrix organization to build and maintain the positive relationships required to accomplish project goals along with coach / mentor the organisation audit function
- Effective compliance reporting to senior management and relevant quality governance forums
- Must have excellent written and verbal communication skills.
What you will receive:
- Competitive salary & benefits package, career advancement & development opportunities
To apply for this position please contact Chloe Walsh at Sigmar Recruitment T: +353 91 455305 E: firstname.lastname@example.org
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