The main responsibility of the Tech QA Lead is to support qualification and validation activities alongside a team of Quality Engineers/Processors, ensuring the site delivers safe and effective products that meet customer needs whilst maintaining compliance. Responsibility of implementing Quality Validation objectives and ensuring short-term and long-term quality goals are met.

Responsibilities Include
Support the development & implementation of company-wide quality systems & policy compliance to worldwide regulatory requirements including, FDA QSRs, ISO13485 & IVDD.
Perform QA review and approval of validation lifecycle documentation (URS, IQ, OQ,) protocols and reports.
Support and supervise the change control process for QA Validations, ensuring quality objectives and timelines are met.
Ensure validation and qualification activities of processes, methods, and equipment comply with internal requirements and applicable regulations and standards.
Supervise the QA Validation team and liaise with key stakeholders, ensuring validation timelines are met.
Perform and approve risk assessments related to validation activities.
Prepare product quality and process data using statistical techniques to identify trends and implement improvement plans accordingly.
Act as a QA Validation Subject Matter Expert (SME) in support of planned and unplanned changes.
Ensuring alignment of process across the division.
Lead & promote Continuous Improvement initiatives within the department and division.


Education and Years Experience
Bachelors Degree
Relevant third level qualification. Engineering/Manufacturing/Science is preferred.
Minimum 5 years in Engineering/Manufacturing/Scientific.
Supervisory experience preferred