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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.

The **Product Quality Engineer** at Omnicell is responsible for ensuring that our products meet all design, development, and post-market requirements. This role involves leading product change control and product development processes, analyzing data, and maintaining compliance with regulatory standards. The ideal candidate will be versatile, analytical, and detail-oriented, with strong communication and problem-solving skills.

The **Product Quality Engineer III** builds upon the foundational knowledge and responsibilities of the PQE I & II, with added emphasis on leading quality initiatives for specific product lines, managing more complex product changes, and having a greater impact on regulatory compliance. This role requires a deeper understanding of quality processes, the ability to lead cross-functional teams, and independent decision-making.

This position is a remote position to be based in the Greater Pittsburgh area. The ability to commute to our Cranberry Woods, PA / Thorn Hill, PA location is expected on an as needed basis.

Responsibilities:

_Change Control and Design:_

+ Lead the execution of defect management and engineering escalation processes, ensuring timely identification, resolution, and reporting of product issues.

+ Drive the review and approval of design and service verification and validation protocols, with a focus on product changes and lifecycle processes.

+ Manage cross-functional teams in product change control processes and ensure comprehensive documentation of product modifications.

+ Take ownership of maintaining and updating the Device Master Record (DMR) for assigned product lines during post-market changes.

+ Ensure alignment of design outputs with inputs, proactively addressing discrepancies and ensuring compliance with internal protocols.

+ Act as the lead liaison between engineering, product management, and quality teams to integrate quality considerations early in the product design phase.

_Field, Customer and Safety:_

+ Independently process and triage out-of-box quality issues, conducting root cause analyses and collaborating with teams to drive corrective actions.

+ Lead post-production safety risk assessments and implement solutions to mitigate safety concerns.

+ Drive the Medical Device Reporting (MDR) process, coordinating with regulatory bodies and managing field actions and recalls.

+ Present safety and risk management updates during Safety Risk Management Board Meetings, with responsibility for product-specific risks.

_Compliance and Continuous Improvement:_

+ Lead quality improvement projects aimed at optimizing processes, reducing defects, and enhancing customer satisfaction.

+ Ensure adherence to ISO 9001, ISO 13485, and other relevant regulatory standards, acting as a subject matter expert for compliance.

+ Implement and analyze quality metrics, creating reports to monitor process performance and drive data-driven improvements.

+ Conduct internal audits and manage corrective and preventive actions (CAPA) to ensure continued compliance and improvement.

Required Knowledge and Skills:

+ Advanced knowledge of QMS (Quality Management System) documentation and regulatory standards (ISO 9001, ISO 13485).

+ Proficiency in quality investigation tools (e.g., Fishbone diagrams, 5 Whys) and statistical analysis (e.g., SPC, Six Sigma).

+ Experience in leading cross-functional teams and managing product changes from initiation through post-market stages.

+ Strong project management skills and the ability to manage multiple priorities effectively.

+ Excellent problem-solving, communication, and leadership abilities.

Basic Qualifications:

+ Bachelor’s degree in Engineering or Science discipline

Preferred Qualifications:

+ 3-4 years professional experience

+ Experience in product development and/or maintenance

+ Experience in process development

+ Experience working in a regulated environment (i.e. ISO 9001, ISO 13485 or FDA regulated)

+ Experience working with complex electro-mechanical systems

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.