Experience
- Strong experience in a Quality Engineering/Quality Assurance role for Biologics, medical device or pharmaceutical manufacturing.
- Experience in change control, non-conformance, corrective and preventative actions, and validation practices
- Ability to operate across functional boundaries, both internal and external
Knowledge
- Demonstrated knowledge of GxP regulations (e.g. EU-GMP, FDA, ISO)
Qualifications
- Bachelor’s degree in an Engineering or Scientific related discipline.
Behavioural Competencies
- Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration
- Prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
- Critical thinking skills