Quality & Risk Coordinator

1 week ago

Penicuik, Midlothian, United Kingdom Quotient Full time

Building on 30 years of experience in transfusion diagnostics, Quotient is a commercial stage diagnostics company committed to delivering solutions that reshape the way diagnostics is practiced.

Quotient has two key product portfolios, Alba by Quotient and MosaiQTM 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.

MosaiQ is designed to be a game-changing solution, which we believe will increase efficiencies, improve clinical practice, deliver significant workflow improvements and operational cost savings to laboratories around the world.

Quotient's operations are based in Eysins/Switzerland, Edinburgh/Scotland and Chicago/Illinois.

At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life.

With over 30-years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster diagnostic results.

Alba our blood bank reagents portfolio and MosaiQ one of the first multiplexing and multimodality automated testing platformsare designed to make labs more efficient and clinical decision-making more effective.

Our journey started as Alba Bioscience, and later, Quotient. Today, as AliveDx, we innovate for life.

risk coordinator (18 months ftc)

AliveDx is recruiting for a Risk Coordinator to join the Regulatory Affairs and Quality Department based at our Allan Robb Campus near Penicuik, EH26 0BF.

This is a temporary role with flexible working options, working up to 37.5 hours per week.

YOUR MISSION

Your main responsibilities will include:

  • Ensure Product Risk Management Process is compliant with relevant Risk Management Regulations.
  • Lead and/or Support all types of Product Risk Management activities according to procedures in place.
  • Ensure Product Risk Documentation is compliant with procedures in place.
  • Ensure Product Risk Management Process efficiency according to KPIs setup.
  • Act as a Risk Management Team Representative during Third Party Audit
  • Promote risk culture including Risk Based Approach and Continuous Improvement
  • Provide Risk Management Training.
  • Perform any other duties as reasonably requested from the company from time to time.

YOUR COMPETENCIES

  • Science degree or equivalent
  • Risk management and human factor engineering awareness.
  • Process mapping experience.
  • Appropriate experience in a regulated (GMP/GLP) scientific environment.
  • Experience in document preparation / controlled documentation or Quality Assurance.
  • Experience of processing complex documents.
  • Experience in product / process validation.

WHAT WE OFFER

  • A highly dynamic and growing environment.
  • An opportunity to live your passion for intrapreneurial mindset, where cultivating innovation and customer centricity are at the heart of everything we do.
  • A flexible working environment where applicable and a range of core and flexible benefits ranging from private medical cover, life assurance, additional annual leave, cycle to work, technology, experience days and access to marketplace discounts.

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