Senior Quality Engineer
Job ID: JOB-11456
Senior Quality Engineer
A leading medical device company in Galway is looking to hire a Senior Quality Engineer to join their team on a permanent basis.
The Senior Quality Engineer provides a support role to the IDEM Business Unit including Manufacturing Sites. The Senior Quality Engineer reports to the Quality Operations Director/Manager, IDEM.
Responsibilities and Duties
- Possesses and applies comprehensive knowledge of Quality, and its application to the completion of complex assignments.
- Advanced knowledge of the organization’s operations and practices to enable informed decisions, and providing direction to Quality team and other functional areas.
- 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.
- Makes decisions under conditions of uncertainty, sometimes with incomplete information, that produce effective end results. Applies risk assessment techniques in such circumstances.
- Independently performs assignments with instruction limited to results expected. Determines and develops approach to 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 the organization.
Education & Experience
- 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.
For further information on this role please contact Clara Burke on 086 816 8273 or firstname.lastname@example.org
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