Life Science Recruitment Leader | Pharmaceuticals | Medical Device R&D | Contract Recruitment | 087 402 0020 | cormac@stemrp.ie
We are seeking a hands‑on Senior or Lead Quality Engineer to support digital transformation initiatives within a rapidly growing medtech and greenfield operation in Galway.
This role will focus on integrating quality systems with digital manufacturing technologies, ensuring full compliance, and driving continuous improvement across electronic data and quality management workflows.
The successful candidate will act as a digital quality champion who will execute system implementations, ensure regulatory compliance, and embed quality into automated, data‑driven environments.
12‑month contract initially, with a view to extension and/or permanency as the company continues to rapidly grow.
Lucrative contractor hourly rates available.
Key Responsibilities
* Maintain and enhance the Quality Management System (QMS) in alignment with ISO 13485 and FDA regulations.
* Ensure compliance with applicable regulations, including FDA, EU MDR, and ISO standards, with specific emphasis on 21 CFR Part 11 electronic record requirements.
* Support digital transformation initiatives by integrating quality controls into automated and data‑driven manufacturing processes.
* Collaborate across cross‑functional teams to embed quality assurance practices into digital workflows, including MES (Manufacturing Execution Systems) and ERP systems.
* Monitor and validate data integrity across digital platforms, ensuring traceability and security.
* Lead or support IQ/OQ/PQ activities for new digital equipment and software systems.
* Maintain accurate documentation of quality‑related activities, including CAPAs, SCARs, and non‑conformance reports.
* Conduct internal and external audits (FDA, Notified Bodies) and ensure continuous audit readiness of digital systems and electronic records.
* Provide training and support for staff on quality systems, regulatory compliance, and electronic documentation practices.
* Provide expert guidance on digital traceability, data governance, and cybersecurity in a regulated environment.
* Actively participate in continuous improvement initiatives and quality performance reviews.
* Oversee and support electronic DHR/eLHR system validation and implementation (Camstar experience advantageous).
* Manage material and process traceability, including Bill of Materials and manufacturing process digitization.
Candidate Requirements
* Bachelor’s degree in Engineering, Quality, or a related discipline.
* Minimum 7–8 years of experience in quality engineering roles within the medical device or pharmaceutical industry.
* Proven experience in digital quality systems, such as ERP, MES, or eDHR platforms.
* Strong understanding of quality systems and regulatory requirements (ISO 13485, FDA 21 CFR Part 11).
* Demonstrated ability to execute projects independently, not just coordinate—must be proactive and technically strong.
* Experience with Camstar, BOM structures, material traceability, and process mapping preferred.
* Continuous improvement mindset with a proactive approach to problem‑solving.
* People leadership experience is advantageous (managing 1–2 direct reports).
* Open, adaptable, and collaborative with strong cross‑functional communication skills.
If interested, please reach out or apply below.
Galway, County Galway, Ireland
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