Quality Engineer

Building on 30 years of experience in transfusion diagnostics, AliveDx is committed to delivering solutions that reshape the way diagnostics is practiced. AliveDx has two key product portfolios, Alba by Quotient™ and MosaiQ™ by Quotient. The Alba by Quotient™ product range is comprised of high-quality reagents used to keep laboratories around the world running efficiently. They are sold directly to laboratories or through our OEM partners. MosaiQ™ by Quotient is our proprietary multiplex microarray technology, offering the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities. AliveDx operations are based in Eysins, Switzerland, Edinburgh, Scotland and Chicago, Illinois.

QUALITY ENGINEER

We are recruiting for a Quality Engineer to join our Quality Team based at our ARC site near Penicuik, EH26 0BF. This role is a full-time, permanent position working 37.5 hours per week. Monday-Friday.

Reporting to the Team Leader, Quality Systems, the Quality Engineer will be responsible for assisting in the maintenance of the quality management system and the records therein. They should look to maintain collaborative relationships with colleagues from all areas of the business and ensure ongoing quality improvement while maintaining compliance with internal procedures and the required standards

JOB DESCRIPTION

The main responsibilities will include:

• routine tasks or assignments, including but not limited to:
• Non-conformance assessment and progression
• Change control assessment and progression.
• Quality meeting preparation and chairing

• Follows prescribed guidelines or procedures to provide solutions to problems such as:
• Root cause analysis
• Trending quality data from key data (e.g. non-conformance, CA/PA)

• Works with limited levels of guidance such that there is:
• Ownership of certain quality issues

• Continues to build knowledge of the business, processes and customers (internal and external):
• Assist during internal/external audits from customers and regulatory bodies
• Compile and contribute to specific quality metrics and trending accordingly
• Identify areas for improvement and contribute to a culture of continuous improvement
• Demonstrate and exhibit all key behaviours as defined by the business
• Participate in an 'in-house' programme of continuous training and assessment

• Conduct all duties in compliance with Good Manufacturing Practice (GMP), Good Documentation Practice (GDP) and appropriate regulatory requirements including statutory Health & Safety legislation and internal practice.

QUALIFICATIONS, EXPERIENCE & BEHAVIOURS REQUIRED

• A relevant degree or equivalent qualification
• Experience at an appropriate level in the Quality function of a business operating to cGMP.
• Understanding of QMS processes, i.e. Non-conformances / Change Controls / CAPA
• Effective time management and prioritisation skills. Ability to self-motivate and participate in team and project work.

• ADDITIONAL INFORMATION
• Competitive salary on offer.
• AliveDx offer a range of core and flexible benefits ranging from private medical cover, life assurance, cycle to work, technology, and restaurant discounts.