The Director Product and Digital Quality is accountable for ensuring design quality, regulatory compliance, and innovation excellence across a complex, globally integrated product development ecosystem
Job Summary
The Director Product and Digital Quality is accountable for ensuring design quality, regulatory compliance, and innovation excellence across a complex, globally integrated product development ecosystem.
This role provides direct ownership of System Design Controls, Software Validation, Non‑Product Software Quality, Process Controls, Product & Information Security, and AI Strategy.
Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives.
Matching Summary
The Director Product and Digital Quality is accountable for ensuring design quality, regulatory compliance, and innovation excellence across a complex, globally integrated product development ecosystem.
Skills & Requirements
Must-have
System Design Controls for Class II devices
Software Validation (product and non-product)
Product & Information Security compliance
AI/ML Quality and Risk Governance
ISO 13485, ISO 14971, IEC 62304
FDA 21 CFR Part 820
Nice-to-have
Agile scrum software development methodology
Continuous improvement culture
Career growth and development
Harnessing Danaher's system
Key Requirements
Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, Electronics, or related field
16+ years in the Medical Device industry
8+ years leading multi-disciplinary teams
Experience with cybersecurity frameworks relevant to Class II devices