Overview
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 platforms––are 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.
AliveDx is recruiting for a Quality Officer to join the Quality Systems team based near Penicuik, Edinburgh. The role is a full-time permanent position, working 37.5 hours.
The ALBA Quality and Regulatory Affairs group comprises a number of smaller teams who together establish the Quality/Regulatory link between ALBA products and the end user. The Quality Officer role is part of the Post Market Quality team, who are responsible for the management of Complaints, Post Market Surveillance (PMS) and Product Risk Management for all Alba Products.
Responsibilities
* Working knowledge of QMS concepts and procedures; performs a variety of routine tasks associated with Complaints, Risk and PMS.
* Chair cross-functional meetings.
* Support / participate in internal/external audits from customers and regulatory bodies
* Providing support, guidance and training as needed to fellow team members in the Post Market Quality Areas of expertise
* Maintains up-to-date knowledge of products and process within the business
* Perform any other duties as reasonably requested from the Company from time to time.
* Conduct all duties in compliance with Good Manufacturing Practice (GMP), Good Documentation Practice (GDP) and appropriate regulatory requirements.
* Record and manage customer complaints within the eQMS in compliance with internal procedures
* Review investigation reports and prepare customer communications ensuring clarity and regulatory suitability
* Carry out Risk Management activities throughout the product life-cycle in accordance with applicable regulations and standards.
* Promote risk culture within Alba including Risk Based Approach and Continuous Improvement
* Carry out Post Market Surveillance (PMS) activities for Alba Bioscience products in adherence with the required schedules to ensure regulatory compliance
Your Competencies
* Risk Management or Quality Systems/Engineering qualifications/training.
* Science degree or equivalent qualification, or a relevant degree combined with appropriate industry experience.
* Strong understanding of QMS processes, i.e. Customer Complaints, CAPA, change management
* Ability to analyse, trend and present quality and PMS data in accordance with procedures.
* Knowledge of applicable medical device / IVD regulations and standards.
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.
Interested?
We look forward to receiving your application.
AliveDx is an equal opportunity employer and welcomes applications from all qualified individuals regardless of nationality, sex, disability, region/belief, sexual orientation or age. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on competences, performance and business needs.
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