QA Specialist

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

Job summary

QCS Staffing is seeking a QA Specialist to support a life-changing pharmaceutical organisation in Dublin on an initial 12‑month contract. The role focuses on ensuring compliance and readiness for regulatory inspections within the Medical Device/Combination Product space.

You will help progress documentation, support audit activities, and analyze QMS data to support Management Review meetings and actions. A regulated industry background and experience with electronic QMS tools are essential.

Qualifications

• Bachelor's degree or equivalent in a regulated industry.
• Knowledge of regulatory/compliance requirements for medical devices (FDA QMSR 21 CFR Part 820, Part 4; ISO 13485; EU 2017/745; ISO 14971).
• Experience using electronic QMS / document management systems (e.g., Veeva Vault).
• Experience managing quality/compliance projects in a regulated medical device environment.

Responsibilities

• Support the Medical Device Quality Team in progressing updates and release of documents & records in the document management system.
• Support Combination Product Audit readiness initiatives and during audits.
• Support Notified Body and Health Authority inspections and compliance.
• Collect/collate QMS data and perform data analysis for periodic Management Review reports, meetings, minutes and actions.

Skills

Quality project management

Regulatory knowledge

Education

Bachelor's degree or equivalent

Tools

Veeva Vault

Job description

QA Specialist – Medical Devices – Dublin – Initial 12-Month Contract – Pharmaceuticals

Are you looking for the chance to support a life changing pharmaceutical organisation in their mission to continuously drive innovation? We are recruiting for a QA Specialist to support a project in Dublin on an initial 12-month contract.

What You’ll Deliver

• Supporting the Medical Device Quality Team in progressing the update and release of documents & records in the document management system.
• Supports Combination Product Audit readiness initiatives and support during audits.
• Supports Notified Body and Health Authority inspections and compliance.
• Responsible for collection/collation of QMS data and performing data analysis to support periodic Combination Product Management Review reports, meetings, minutes and actions.

Experience required:

• Minimum of a bachelors degree or equivalent experience in a regulated industry.
• Knowledge of the regulatory and compliance requirements for medical devices and/or combination products (e.g. FDA QMSR 21 CFR Part 820 and Part 4 / ISO 13485 and Regulation (EU) 2017/745), ISO 14971.
• Experience using electronic QMS / document management systems (e.g., Veeva Vault) for document lifecycle, quality events, and action tracking.
• Demonstrated experience managing quality or compliance- related projects in a regulated medical device and/or combination product environment.