Gentian Health is looking for a Quality Technician to join the quality team, supporting the Design and Manufacture of a range of devices within a customer-facing medical device contract design and manufacturing organisation. This role supports the Quality function by maintaining ISO 13485 / 21CFR 820 compliant Quality management systems. The main function of this position is to perform Quality inspections and audits at incoming inspection and throughout the manufacturing process at Gentian Health.
Responsibilities:
* Attention to detail.
* Ability to prioritise tasks and work to instruction.
* Proficiency in good documentation practices (GDP).
* Previous experience with eQMS, e.g. QT9 an advantage.
* Ability to work as a team member.
* Perform Quality inspections on finished goods and sign off Quality inspection Device History Records (DHR’s) paperwork.
* Ensure DHR’s are completed and maintained.
* Perform Incoming Inspections, material disposition, and follow up with procurement department.
* Support Operations and Quality function in tracking, documenting, and reporting Quality levels as well as looking into other Key Performance Indicators (KPI’s).
* Audit Good Manufacturing Practices (GXP) in the production area.
* Work with all team members to support corrective action investigations.
* Support Quality department in managing the Quality Management System on QT9.
* Responsible for good housekeeping and safety procedures in the inspection areas.
* Conduct Electrostatic Discharge (ESD) audits to assess compliance with ESD requirements within production.
* Escalation of Quality issues as appropriate.
* Supports Quality in creating procedures, specifications, and standards for products and processes.
* Advance Microsoft Office user e.g. Word, Excel, and email.
* Participates and completes training in a timely manner.
* Good communication skills.
* Follow and adhere to company policy and procedures including Health & Safety and other regulatory requirements.
* Any other tasks and requirements as directed.
Education Requirements:
* Level 7 Degree or equivalent in Quality, Engineering, Science, or Technical discipline.
Experience / Knowledge / Skill Requirements:
* Internal Auditor Training an advantage.
* Cleanroom Experience an advantage.
Gentian Health is a Medical Device Contract Design and Manufacturing company specializing in electromechanical, bio-sensing surgical & medical devices. Our products include electronic sensor-based devices and single-use minimally invasive surgical devices. As part of our service, we offer Design for manufacturing, Design and process validation, Clinical trial batch build, NPI and scale-up, along with scale manufacturing on an ongoing basis.
Job Types: Full-time, Permanent
Pay: €27,000.00-€30,000.00 per year
Benefits:
* Company pension
Schedule:
* 8 hour shift
* Day shift
* Monday to Friday
Ability to commute/relocate:
* Shannon, CO. Clare: reliably commute or plan to relocate before starting work (required)
Work authorisation:
* Ireland (required)
Work Location: In person
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