Staff Quality Engineer

Omnicell•Pittsburgh, PA

59d

About The Position

Omnicell is seeking a Staff Quality Engineer that will report into a Manager or Sr. Manager of Product Quality. The Product Quality team partners with product management, engineering, and customer-facing organizations to consistently fulfill the needs of our customers by providing end-to-end quality support for our products and services through the execution of our QMS processes. This specific role will be supporting the new product development of software including requirement development, verification and validation strategies and testing, and compliance with regulatory standards.

Requirements

Bachelor's degree in Engineering or Science discipline
3-6 years professional experience
Cloud/SaaS experience
Experience in product development

Nice To Haves

7+ years professional experience
Experience in process development
Experience working with medical devices (i.e. ISO 13485 or FDA regulated)
Expertise in machine learning and generative AI

Responsibilities

Serve as the primary quality representative in the development of On-premise, Edge, Cloud and SaaS software collaborating with engineering, product management, and operations to ensure quality is embedded into the product.
Establish touchpoints and the level of sprint and backlog engagement required for efficient quality support of software development.
Liaise with Regulatory and other Quality departments throughout the product development process for necessary inputs into development.
Work with safety risk management and the supporting team to create a risk file during the development of the product and ensure the incorporation of appropriate design mitigations.
Review and approve verification and validation protocols, and final design outputs, ensuring consistency with quality, regulatory and safety standards.
Champion continuous improvement initiatives, identifying opportunities to enhance product quality and optimize internal processes.
Develop and implement advanced quality metrics, presenting findings to senior leadership and drive actions to meet key performance indicators (KPIs).
Support post-market surveillance activities including software patch validation, complaint trending, and field issue resolution.
Support external audits and regulatory inspections, ensuring full compliance with ISO and other relevant regulatory bodies.
Knowledge of QMS processes and regulatory standards (ISO 9001 or 13485).
Demonstrated ability to lead large-scale quality projects, including product development and risk mitigation.
Strong leadership and decision-making skills, with the ability to influence cross-functional teams and senior leadership.
Experience working with software engineers throughout sprint and release processes.
Exceptional technical communication skills.