Post-Market Quality Officer: Risk & PMS Champion

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

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.