eQMS Quality Lead
DeWinter Group
- Westbrook, Maine, United States
- Westbrook, Maine, United States
À propos
eQMS Quality Lead
Job Type:
Contract
Contract Length:
8 months
Pay Range:
$50-55/hr
Start Date:
ASAP
Location:
Remote - East Coast strongly preferred (ideally someone who is able to drive to Maine, if needed in the future)
About the Opportunity Our client, a leader in Healthcare, is looking for a skilled
eQMS Quality Lead
to join their team for an 8‑month engagement. This project involves providing hands‑on support for validation testing of an enterprise Quality Management System (QMS), ensuring the system is validated, compliant, and fit for use in a regulated environment. This is a high‑impact role that requires a self‑motivated professional who can hit the ground running and deliver results quickly.
Key Responsibilities & Deliverables
Lead requirements‑based validation of QMS functionality, including the development and execution of Functional Requirements Specifications (FRS) and Operational Qualification (OQ) test cases.
Execute validation activities (e.g., OQ/PQ), perform risk‑based testing, and produce complete, audit‑ready validation documentation and execution evidence.
Plan and execute integration testing between the QMS and connected enterprise systems (e.g., ERP, HR, training, or document repositories).
Support internal and external audits by providing validation documentation, test evidence, and subject‑matter expertise.
Partner with Quality, IT, Regulatory, and Business stakeholders to ensure QMS solutions meet compliance, usability, and scalability needs.
Required Skills & Experience
Demonstrated experience testing or validating regulated systems, such as a Quality Management System (QMS).
Deep expertise in QMS testing, Validation and Documentation Discipline, and strong knowledge of requirements‑based testing and traceability.
Experience creating and executing formal test cases with documented evidence.
Familiarity with audit and inspection expectations for computerized systems.
Strong communication skills with the ability to translate regulatory and quality expectations into practical testing strategies.
Demonstrated ability to work autonomously and manage your own time effectively to meet project goals.
W2 only (No C2C or 1099 contractors)
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Compétences linguistiques
- English
Avis aux utilisateurs
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