Quality Officer, Post Market Quality

AliveDx; Penicuik; On-site; GBP 30,000 - 50,000; Full time

Benefits offered by this job

Private medical cover

Life assurance

Additional annual leave

Cycle to work

Experience days

Marketplace discounts

Job summary

AliveDx in Penicuik, Edinburgh region seeks a Quality Officer to join the Post Market Quality team. The role centers on managing Customer Complaints, Post Market Surveillance and Product Risk for Alba products, with a 37.5-hour week.

You will support audits, provide guidance to teammates, and maintain up-to-date product knowledge while ensuring GMP/GDP compliance and regulatory alignment across the business.

Qualifications

• Science degree or equivalent qualification.
• Knowledge of GMP and GDP principles.
• Understanding of QMS, CAPA and change management.
• Ability to analyse and trend quality and PMS data.
• Familiarity with medical device/IVD regulations.

Responsibilities

• Manage customer complaints, PMS and product risk across Alba products.
• Chair cross-functional meetings and support audits from customers/regulators.
• Provide guidance and training within Post Market Quality teams.
• Maintain up-to-date knowledge of products and processes.
• Record and manage complaints in the eQMS and ensure regulatory compliance.
• Review investigation reports and prepare compliant communications.
• Carry out PMS activities and promote risk-based continuous improvement.

Skills

Risk management

Quality systems

Regulatory knowledge

Data analysis

Education

Science degree or equivalent

Job description

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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.

QUALITY OFFICER – Post Market Quality

AliveDx is recruiting for a Quality Officer to join the Post Market Quality 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 Customer Complaints, Post Market Surveillance (PMS) and Product Risk Management for all Alba Products.

YOUR MISSION

Your main responsibilities will include:

• 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
• Maintain 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 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.