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 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, 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 to ESD requirements within production.
- Escalation of Quality issues as appropriate.
- Supports Quality in creating procedures, specifications, and standards for products and processes.
- Ability to work as a team member.
- Advance Microsoft office user e.g. Word, Excel and email.
- Participates and complete 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
- Supervisory Responsibilities:
- Oversees all Quality employees and consultant workload and deliverables.
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:
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:
Work Location: In person
