Sr. Quality Engineer

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.

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.

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
• Experience working in a regulated environment (i.e. ISO 9001, ISO 13485 or FDA regulated)
• Hands-on experience within product development
• 3+ years professional experience within quality space

Preferred Qualifications

• Experience in process development
• Experience with 14971 regulations
• Experience working with complex electro-mechanical systems

Work Conditions

• Office Environment
• May travel up to 25%