Overview
Quality Engineer role at AliveDx. The position is based at our ARC site near Penicuik, EH26 0BF. This is a full-time, permanent position working 37.5 hours per week, Monday–Friday. Reporting to the Team Leader, Quality Systems.
AliveDx is a company with more than 30 years in transfusion diagnostics, focused on delivering solutions that reshape diagnostics. Our product portfolios include Alba by Quotient and MosaiQ by Quotient. AliveDx operates from Eysins, Switzerland; Edinburgh, Scotland; and Chicago, Illinois.
Responsibilities
* Assist in the maintenance of the quality management system and the records therein.
* Maintain collaborative relationships with colleagues across the business to ensure ongoing quality improvement while complying with internal procedures and required standards.
* Contribute to preparation and chairing of quality meetings.
* Perform routine tasks and assignments, including non-conformance assessment and progression, and change control assessment and progression.
* Follow prescribed guidelines to provide solutions to problems, including root cause analysis and trending quality data (e.g., non-conformance, CA/PA).
* Own and address quality issues with limited supervision; participate in continuous knowledge-building of the business, processes, and customers (internal and external).
* Assist during internal and external audits from customers and regulatory bodies; compile and contribute to quality metrics and trending.
* Identify areas for improvement and contribute to a culture of continuous improvement.
* Demonstrate and exhibit key behaviours defined by the business; participate in in-house continuous training and assessment programs.
* Ensure compliance with GMP, GDP, and applicable regulatory requirements, including statutory Health & Safety legislation and internal practices.
Qualifications, Experience & Behaviours
* Experience in the Quality function of a business operating to cGMP.
* Understanding of QMS processes (Non-conformances, Change Controls, CAPA).
* Effective time management, prioritisation, self-motivation, and ability to participate in team and project work.
* Additional information: Competitive salary; core and flexible benefits (private medical cover, life assurance, cycle to work, technology and restaurant discounts).
Job Details
* Seniority level: Associate
* Employment type: Full-time
* Job function: Quality Assurance and Other
* Industries: Manufacturing and Medical Equipment Manufacturing
Location highlights: Edinburgh, Scotland, United Kingdom and surrounding areas have multiple related roles and postings in the area.
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