Product Quality Professional
Swords, Dublin
Are you passionate about improving global healthcare, tackling complex challenges, and expanding access to care? Our client, a leading diagnostics company, is looking for a dedicated Product Quality Professional to join their team and support high-impact work in healthcare.
Overview:
As a Product Quality Professional, you will be essential in upholding and enhancing quality standards throughout the manufacturing process. This role includes leading activities such as process change, risk assessment, CAPA, and managing non-conformance and validation processes. You'll act as a bridge between Quality Assurance, Manufacturing, R&D, and Documentation Control teams, focusing on refining quality systems for optimal performance.
Key Responsibilities:
* Lead quality-focused processes including CAPA, non-conforming materials management, complaint handling, and manufacturing deviations.
* Drive change management through verification, validation, and continuous improvement projects.
* Collaborate cross-functionally to update quality system procedures, ensuring compliance and streamlined processes.
Required Skills & Experience:
* 5+ years in a regulated environment, with experience in FDA regulations and Risk Management.
* Relevant qualification in Quality Management, Mechatronics, Electronics, or Mechanical Engineering (Diploma/Degree).
* Strong communication skills and experience in cross-functional teamwork.
* Proficient in systems-level thinking, statistical analysis, and tools such as Minitab and MS Office.
* Knowledge of diagnostic technologies (Immunology, Biochemistry, Hematology) is beneficial.
This role provides a unique opportunity to work within a global team of dedicated professionals and make a significant impact on healthcare outcomes.
If you're ready for a challenging and rewarding role with opportunities for growth, apply today!