Quality Systems Engineer
Quality Systems Engineer
A well know Galway Medical Device company has a new opportunity for a Quality Systems Engineer to join their team on a full time and permanent basis. As the successful candidate, you will have experience in a role where you were responsible for the implementation, coordination and continuous review of the CAPA and company Compliance programs. In this role, you will be instrumental in conducting audits and in the position of shaping this function within the business. Patient care is at the forefront of the companies invocation and seeking a Quality Systems Engineer who demonstrate a commitment to patient safety and product quality.
- 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.
- Responsible for the implementation, co-ordination and continuous review of the CAPA, Internal and Corporate Compliance programs.
- Offer expertise in internal auditing techniques and is familiar with all regulatory requirements (e.g., FDA, ISO and MDD).
- 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.
- Ensure others are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
- Drives changes in procedures and standards to facilitate work efficiency and to maintain quality.
- Familiar with the internal auditing systems.
- Lead and proactively follows through on the Environmental Management Procedures that have been identified.
- Acts as a leader of quality, QSR and ISO/MDD standards within the 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.
- Lead and 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.
As the successful candidate, you will be:
- 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.
- Must have excellent written and verbal communication skills.
- Strong influence management skills.
- Demonstrate 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
- Degree qualified in Science, Quality or any other STEM discipline.
- 3-5+ years in a Medical Device / Pharmaceutical environment, including practical experience of working within a highly regulated quality management system (QMS).
- Experience in the implementation of ISO 13485, ISO 14971, MDR is essential.
- Accredited lead auditor against recognised quality standards in support of internal audits
For further information on this Quality Systems Engineer role please contact Marchon Monroe on 086 044 9473 / talent@HERO.ie
Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/
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