Job Details

Overview

A medical device company in the Bay Area is seeking an experienced eQMS Implementation Contractor to lead the full transition from their current electronic Quality Management System to a new platform. This is a hands-on, end-to-end engagement — from platform evaluation and selection support through validation, data migration, and go-live. The ideal candidate has done this before and can hit the ground running with minimal ramp time.

What You'll Be Doin

• gLead the end-to-end eQMS platform transition, including requirements gathering, vendor evaluation support, system configuration, and deploymen
• tDevelop and execute validation documentation (IQ/OQ/PQ) in compliance with 21 CFR Part 11, ISO 13485, and applicable GMP standard
• sManage data migration from the legacy system, ensuring traceability, integrity, and continuity of quality record
• sCoordinate cross-functionally with Quality, IT, Regulatory, and Operations to ensure business requirements are captured and me
• tDevelop SOPs, work instructions, and training materials for the new platfor
• mTrain end users and support change management throughout the transitio
• nEnsure the new system is audit-ready and fully validated at go-liv

e
What You Ne

• edHands-on experience leading at least one full eQMS implementation or platform migration in a regulated medical device or life sciences environment — this is a hard requireme
• ntStrong working knowledge of 21 CFR Part 11, ISO 13485, and CSV/validation best practic
• esFamiliarity with common eQMS platforms (e.g., Veeva Vault, MasterControl, Qualio, Greenlight Guru, ETQ, or simila
• r)Ability to work independently and manage the project with minimal oversig
• htStrong documentation, communication, and project management skil
• lsExperience working within a small-to-mid size company (under 200 employees) preferr

ed
Nice to H

• aveExperience selecting and onboarding a new eQMS ven
• dorBackground in quality engineering or quality systems beyond just IT/validat
• ionFamiliarity with Bay Area medical device regulatory environm