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Senior Product Quality Engineer

Omnicelli s seeking a Senior 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 hardware including requirement development, verification and validation strategies and testing, and compliance with regulatory standards.

Responsibilities:

+ Serve as the primary quality representative in the development of hardware collaborating with engineering, product management, and operations to ensure quality is embedded into the product.

+ Ensure hardware development is aligned with the holistic product offering including system engineering strategies and software interfaces.

+ 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.

+ Support design transfer activities to ensure product specifications and quality requirements are effectively communicated to manufacturing and supply chain teams.

+ Champion continuous improvement initiatives, identifying opportunities to enhance product quality and optimize internal processes.

+ Implement quality metrics and drive actions to meet key performance indicators (KPIs).

+ Support post-market surveillance activities including complaint trending, defect management and field issue resolution.

+ 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 hardware engineers and electro-mechanical systems.

+ Exceptional technical communication skills.

Basic Qualifications:

+ Bachelor’s degree in Engineering or Science discipline

+ 3-4 years professional experience

+ Experience in product development

Preferred Qualifications:

+ 5+ years professional experience

+ Experience in process development

+ Experience working with medical devices (i.e. ISO 13485 or FDA regulated)

Work Conditions:

+ Office Environment

+ May travel up to 10%

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.