Quality Engineer

Lead and coordinate quality and validation activities related to production transfers and manufacturing changes.

Create, review, approve validation documentation including plan / protocols, reports, process control plan  and associated controlled documentation.

Participate in process, equipment and manufacturing validations and ensure compliance with applicable quality and regulatory requirements.

To ensure that validation activities are appropriately planned, executed, and documented to maintain compliance of manufacturing processes, equipment, and associated documentation within controlled manufacturing and cleanroom environments.

Participate in transfers of products and manufacturing processes between Novanta sites from a quality and validation perspective.

Collaborate closely with Project Management, Regulatory Affairs, Operations and Quality teams to ensure successful implementation of changes.

Create, review, approve risk management documentation (PFMEA).

Evaluate impact of manufacturing changes to validation status and support implementation activities.

Support internal, customer and certification audits.

Support root cause investigations and continuous improvement activities using appropriate quality tools

Experience working in a regulated manufacturing environment such as medical devices, pharmaceuticals, biotechnology, food supplements or similar industries

Hands-on experience with validation activities and controlled documentation

Knowledge of quality standards and regulations (ISO 13485, ISO 9001, GMP or similar)

Experience working in cleanroom or controlled manufacturing environments is highly desirable

Ability to work independently while collaborating effectively within cross-functional teams

Strong documentation and communication skills

Fluent Czech and English