Quality Engineer

PE Global; Sligo; On-site; EUR 50,000 - 70,000; Full time

Job summary

PE Global is recruiting a Quality Engineer for a leading pharmaceutical company in Sligo on a 12‑month contract. You will ensure product compliance with specifications and GMP, working as part of the Quality Team to meet quality goals.

Responsibilities include coordinating the Quality System, handling CAPA, investigations, batch release, supplier quality, and regulatory compliance. The role requires a degree in engineering/science and 2+ years in a regulated quality environment.

Qualifications

• Degree in engineering, science, or quality discipline.
• Green Belt and statistical knowledge desirable.
• At least 2 years in day‑to‑day quality system operations in a regulated manufacturing environment.
• Experience in injection moulding or tooling environment is desirable.

Responsibilities

• Coordinate elements of the Quality System to ensure GMP compliance.
• Audit the quality system with relevant personnel.
• Assist in investigation of customer complaints and CAPA actions.
• Manage day‑to‑day CAPA initiation, investigation, correction and follow‑up.
• Measure performance of the Quality System and provide monthly metrics.
• Provide training to plant personnel on quality requirements.
• Keep management informed of system failures for corrective/preventive actions.
• Verify effectiveness of CAPA and non‑conformances.
• Ensure compliance with regulatory requirements and assist validation activities.
• Ensure QMS documentation is thorough and compliant.
• Review batch records and perform lot release for shipment.
• Inspect incoming product and manage supplier Quality relationships.
• Participate in continuous improvement programs across quality, safety, environment and production.
• Review batch records and complete disposition where required.
• Participate in risk management activities.

Skills

Statistical knowledge

Quality system awareness

Regulatory compliance

Education

Engineering/Science degree

Quality assurance in regulated environment

CFR 21 Part 820 knowledge

ISO13485 knowledge

Job description

The role:

PE Global is currently recruiting for a Quality Engineer on behalf of a leading pharmaceutical company based in Sligo. This is an initial 12 month contract.

Description:

• To ensure that product manufactured at the site complies with approved specifications and that activities at the site comply with current good manufacturing practice and Regulatory Agency requirements.
• To work as a member of the Quality Team to ensure that Quality goals and objectives are achieved. Ensure that all actions comply with current good manufacturing practice.

Key Responsibilities:

• 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.
• Ensure all plant personnel are fully aware of quality requirements (where relevant) by providing the necessary training.
• Ensure Management is kept informed of all system failures to ensure corrective/preventive action and product containment is taken where necessary.
• Verification of effectiveness of corrective/preventive actions arising out of product process and quality system non‑compliance.
• Ensure implementation and compliance with relevant Regulatory requirements.
• Assist in the performance of validation activities at the site.
• Ensure Quality System documentation is thorough, complete, and compliant.
• Ensure compliance to training requirements is maintained.
• Review lot records, ensuring documentation is compliant to requirements and completing lot release for shipment.
• Inspect incoming product and manage the supplier Quality relationship.
• Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems at the site.
• Complete in‑process and final release product testing per the relevant approved specifications and procedures.
• Where required. Review batch records, ensuring documentation is compliant to requirements. Complete disposition decision for the batch.
• Participate in Risk Management activities as required.

Education and Experience:

• Degree in an 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.
• 2 years plus experience in the day‑to‑day operation of the quality system in a highly regulated combination product/device manufacturing environment.
• Minimum 2 years 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

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***