Quality Engineer

QCS Staffing Ltd; Sligo; On-site; EUR 45,000 - 60,000; Full time

Job summary

QCS Staffing Ltd is recruiting a Quality Engineer for a role in Sligo, Ireland on an initial 12-month contract with a global pharmaceutical client. The incumbent will support state-of-the-art manufacturing and ensure compliance of the Quality System across the plant.

The role requires a degree in Engineering, Science, or Quality, with Green Belt or statistical knowledge desirable. Experience in regulated manufacturing and quality systems such as ISO13485/ISO9000 and CFR 21 Part 820 is

Qualifications

• Degree in Engineering, Science, Quality or other discipline.
• Green Belt or knowledge of statistics desirable.
• Experience with quality systems in a highly regulated manufacturing environment.
• Experience in injection moulding or tooling desirable.

Responsibilities

• Coordinate appropriate assigned elements of the Quality System, ensuring full compliance by all relevant plant personnel with its requirements.
• Audit the quality system with other personnel where required.
• Assist in the investigation and coordination of customer complaints and assess need for implementation of effective corrective or preventive actions.
• Manage day-to-day CAPA requirements by ensuring timely and effective initiation, investigation, correction and corrective actions.
• Measure performance of the Quality System and providing metrics, for inclusion in the management review, monthly reports etc.

Skills

Quality systems

Audit experience

CAPA management

Statistical knowledge

Education

Engineering degree

Science degree

Quality discipline

Job description

Quality Engineer – Sligo, Ireland – Initial 12-Month Contract – Life Sciences Located near Sligo, our global pharmaceutical client is seeking a Quality Engineer to support their state‑of‑the‑art manufacturing facility. The company focuses on investing in research and development to drive scientific innovation and deliver life‑changing medicines. With project worldwide and continued growth across their network, this is an excellent opportunity to support a leading organisation shaping the future of healthcare.

What you’ll deliver:

• Coordinating appropriate assigned elements of the Quality System, ensuring full compliance by all relevant plant personnel with its requirements.
• Audit the quality system with other personnel where required.
• Assist in the investigation and coordination of customer complaints and assess need for implementation of effective corrective or preventive actions.
• Manage day-to-day CAPA requirements by ensuring timely and effective initiation, investigation, correction and corrective actions.
• Measure performance of the Quality System and providing metrics, for inclusion in the management review, monthly reports etc.

Experience required:

• Degree in Engineering, Science, Quality or other discipline with experience as deemed suitable by Quality Manager.
• Green Belt qualified or demonstrated knowledge of statistics in an industrial environment is desirable.
• Extensive experience in the day-to-day operation of the quality system in a highly regulated combination product/device manufacturing environment.
• Strong working knowledge of quality systems regulations (ISO13485/ISO9000; CFR 21 Part 820) or individual elements within the regulations such as; process validation, design controls, CAPA, auditing, etc., is desirable.
• Experience in an injection moulding or tooling environment is desirable.