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
Software Validation
Product & Information Security
AI Strategy
Class II medical devices
ISO 13485
FDA 21 CFR Part 820
Nice-to-have
Continuous improvement culture
Agile scrum methodology
Digital QMS tools
Key Requirements
Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, Electronics, or related field
16+ years in Medical Device industry
8+ years leading multi-disciplinary teams
Experience with Class II devices
Experience with ISO 14971, IEC 62304, IEC 82304, ISO-27001, ISO 42001