Engineer III - Quality Systems & Documentation
Core
Lead quality documentation standardization, supplier quality governance, and Bill of Quality readiness across the global Contract Manufacturing network.
Role type
Senior IC Quality Systems Engineer
Builds
Consistent quality documentation frameworks, audit-ready evidence packages, and supplier quality governance routines
Domain
Life Sciences / Regulated Manufacturing (Medical Device, Pharma, Diagnostics)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality systems thinking, supplier quality governance, risk-based decision-making, audit readiness, cross-functional collaboration, continuous improvement, compliance discipline, structured problem solving
Preferred skills
Contract manufacturer support, ISO 13485/FDA QSR/GMP knowledge, process validation expertise, PLM/ERP/eQMS familiarity, stakeholder management in global matrix
Technologies
PLM, ERP, eQMS, SharePoint, document management systems
Responsibilities
Develop and deploy quality documentation frameworks and governance routines; Support Bill of Quality framework development; Define supplier quality documentation requirements for technology transfers; Partner with Quality and Operations to align documentation with regulatory expectations; Support audit readiness by ensuring controlled documents and evidence packages are accurate; Review and improve supplier quality documentation including control plans and CAPA evidence; Lead continuous improvement initiatives to reduce documentation defects; Contribute to technology transfer readiness reviews; Maintain quality best-practice libraries and reusable templates; Partner with digital teams to improve quality record structure and lifecycle governance
Seniority
Senior, hands-on IC
