Quality Assurance Associate

We are looking for a proactive and detail-oriented Quality Assurance Associate to join our Cambridge-based Quality function within a regulated medical device manufacturing environment operating to ISO 13485, MDSAP, EU IVDR and FDA requirements.

You will combine strong technical and analytical thinking with excellent interpersonal skills. You will need to be comfortable working with controlled processes, procedures, records and data, with the attention to detail and critical thinking necessary to identify inconsistencies, investigate issues and ensure that quality principles are applied.

The role requires an individual who can build positive relationships with colleagues across Quality, Manufacturing, Operations, R&D and other functions. You should be able to explain quality requirements clearly, listen to different perspectives and challenge constructively.

You'll need to be organised and resilient, comfortable juggling multiple priorities and able to take ownership of actions through to completion.

Your duties will include:

Quality Management System

• Maintenance and administration of the Quality Management System, including the establishment and maintenance of core quality SOPs
• Assisting in implementing the eQMS
• Supporting quality processes including:
  • Internal and external auditing
  • Supplier control and performance monitoring
  • Induction and training
  • Handling of external party enquiries and data requests
• Monitoring of QMS performance through:
  • Input into the definition of quality objective and KPI metrics
  • Monitoring, analysis and reporting on quality KPIs
  • Reporting & action on KPIs through the Quality Management Review framework
• Supporting continuous improvement through the implementation of delegated tasks in the Quality Plan & Quality Events.

Product and Processes Quality Events

• Providing administrative support to quality events investigations:
• Participation in product and process quality event investigations root cause analysis and corrective action.
• Monitoring actions status for the resolution of QMS process related Quality Events
• Assisting in the administration of quality event meetings
• Assisting the QC function in document audit for batch release.

Production Process Support

• Providing administrative support to
  • Equipment Qualification tasks, including maintenance and calibration
  • Process Validation tasks
  • Software Validation tasks.

What we’re looking for in you:

Essential

• Degree in a science related subject, biology based or similar discipline or equivalent experience
• 3 - 5 years’ experience working in a Quality Assurance role preferably within a regulated industry to ISO 13485 / 9001
• Strong attention to detail, with the ability to review documents and data for accuracy, completeness and compliance.
• Strong written and verbal communication skills, including the ability to explain quality requirements clearly and professionally.
• Effective interpersonal skills, with the confidence to ask questions, constructively challenge and work collaboratively across different functions and levels of the organisation.
• Competent computer skills and confidence using Microsoft 365, particularly Word and Excel, such as reviewing and formatting of controlled documents, formulas and analysis of data
• Good organisation and time-management skills, with the ability to manage multiple activities, deadlines and changing priorities.

Desirable

• Experience with eQMS and ERP systems
• Experience within a product development, design transfer and manufacturing environment
• Intermediate Excel capability, for example pivot tables, lookups, conditional formatting and analysis/trending of quality data.
• Experience using digital reporting or data-visualisation tools such as Power BI
• Good problem-solving and analytical skills, with experience supporting investigations and corrective actions.

In return you will receive:

• Competitive salary
• Pension Scheme (10% non-contributory)
• Private Health Insurance
• Private Dental Insurance
• Group Income Protection
• Group Life Assurance
• 25 days holiday plus UK bank holidays
• High Street Discount Scheme.