Senior Quality Associate

Are you looking for a change in your career, are you an ambitious, talented and a motivated individual? This could be the role for you!

An opportunity has arisen to join our Regulatory, Medical and Quality Affairs Department, which is responsible for regulatory compliance, generating technical evidence and maintaining the quality systems required for in vitro device manufacture and sales as a QA Associate.

The Senior Quality Associate (Operations) is a quality support position embedded within the operations function. Whilst the role reports to the Director of Quality and is ultimately responsible for quality oversight of GMP and compliance within operations, you will act in a consultancy role providing operations with expert advice for the practical application of quality management procedures, GMP and compliance.

Your duties will include:

• Provide quality oversight of GMP and compliance within operations.
• Provide hands-on practical advice on GMP, GDP and GLP to operations and ensure. compliance with internal procedures and regulatory compliance requirements.
• In collaboration with operations, identify opportunities for improvement:
  • Identifying non-value add activities and supporting lean operations.
  • Assist in process optimisation during design transfer.
  • Implementing a culture of continuous improvement.
• Utilise risk-based tools to assist in continuous improvement and identifying preventative actions:
  • pFMEA and process controls
  • Gemba, internal audits and operational consultation.
• Equipment & Environment
  • Assist quality in the qualification, maintenance, and calibration of manufacturing equipment.
  • Ensuring equipment operating instructions are developed and maintained in accordance with operational requirements and manufacturer’s instructions.
  • Ensuring nonconformance from out of specification and environmental excursion events are managed through the appropriate quality procedures.
• Champion change management
  • Overseeing operational risk and impact assessments and change implementation and confirming compliance in the eQMS.
  • Reporting to the change configuration board
• Managing nonconformance
  • Ensuring product and process identification and quarantine
  • Quality risk management in assessing event criticality.
  • Overseeing operational root cause analysis of operational product and process nonconformance and champion corrective actions in the eQMS.
• Measurement of process and product
  • Assisting in data collection and analysis in accordance with quality objective KPIs for quality management system review
  • Attending management tier and quality management system review meetings
• Supplier Controls
  • Assisting the quality department in monitoring supplier performance and supplier incidents.
• Internal & External Audits
  • Assist in the preparation and performance of operations’ internal audits.
  • Provide support to notified body and any regulatory authority audits.
• Training
  • Assisting quality in defining and coordinating operations’ training plans in the eQMS:
    • Ensuring training plans and material are established and maintained.
    • Monitoring and reporting of training skills confirmations against quality objective KPIs.

What we’re looking for in you:

Essential

• Degree in a science related subject, biology based or similar discipline or equivalent experience
• 5 years’ experience working in a Quality Assurance role preferably within a regulated industry to ISO 13485 / 9001 or equivalent
• Experience of internal auditing
• Experience in manufacturing equipment validation
• Evidence of driving continual improvement in manufacturing and quality processes
• Experience in facilitating teams in the use of quality tools such as pFMEA, root cause analysis and problem solving
• Confidence with complex processes and problems
• Excellent communication skills
• Excellent computer literacy
• Project management experience
• High attention to detail and accuracy.

Desirable

• Experience in the use of an eQMS.
• Experience within a product development, design transfer and manufacturing environment.
• Experience in the validation of software used in a quality management system.
• Experience in supplier management.
• 6-sigma.

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.