Working as part of the Quality Assurance team, you will use your training and skills towards the implementation, maintenance, and continuous improvement of the Quality Management System and ensuring compliance with applicable domestic and international standards and regulations. The qualified individual will be responsible for validation, supplier management, change control and will support other quality system processes. This is a highly visible, hands on position that must be able to work independently and as part of a team.
Description of Duties:
Manage supplier quality, including supplier qualification, quality agreements, maintain approved supplier list (ASL), etc.
Manage overall validation program, including equipment, computerized systems, processes and test methods. Collaborate with owners to develop and execute protocols.
Manage change control process.
Provide training in ISO requirements and quality procedures.
Assist in internal and external audits, including customer audits.
Work with R&D and custom product management for design control implementation for new and custom products, including defining user needs, risk management, verification and validation, design review requirements, etc.
Support nonconformance, deviation, complaint, and CAPA systems. Work with investigation owners to assess root cause, corrections, corrective actions, preventative actions and effectiveness.
Support review and approval of batch records as needed.
Support document and record control as needed.
Report and analyze monthly quality system metrics from excel logs and electronic Quality Management System.
Lead quality improvement projects, including planning, communicating, developing action plans, and providing regular project updates.
Assure compliance with all in-house or external specifications to standards.
Identify quality issues/discrepancies and effectively resolve discrepancies within the organization.
Other duties as assigned.
Job Qualifications:
BS Degree in scientific discipline.
Job Type: Full-time
Pay: £30,434.00-£44,777.00 per year
Benefits:
* Life insurance
Work Location: In person