Senior Quality Engineer
The Senior Quality Engineer reports to the Quality Operations Director/Manager, IDEM. The role is based in Galway, Ireland
What You Will Do:
- Responsibility for delivery of projects originated in QA or participate within Core Team for Quality deliverables of business wide projects
- Identifies key barriers/core problems and applies problem-solving skills in order to deal creatively with complex situations. Troubleshoots and resolves complex problems with effective solutions.
- Drives business improvements through mentoring and support for the continuous improvement initiatives.
- Escalation point for quality related non-conformances and CAPAs.
- Drives compliance cross functionally in alignment with the objective for collaboration and multi-site standardisation and compliance.
- Drives compliance across Business Unit through communication and collaboration to ensure that Quality System requirements are met throughout ARDx.
What You Will Need:
- Third level qualification.
- Minimum 5 years of experience in medical device industry with minimum 3 year of progressively responsible positions, including: competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP),
- Awareness of relevant laws and regulations (e.g. CE/ FDA/ PAL)
- Broad knowledge of engineering and technical applications applied in development of medical devices useful
- Excellent interpersonal, written and verbal communication skills, including ability to make clear, well founded decisions regarding conformity during audits.
- Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
- Proficient with MS Word, Excel, Power Point, and management of spreadsheets.
What You will Receive:
- Competitive salary, career progression & training & 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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