Omnicell Specialty Pharmacy Services · 1 day ago
Product Quality Engineer III
Cranberry Township, PA, United States
Full-time
Hybrid
Mid, Senior Level
3+ years expOmnicell Specialty Pharmacy Services is committed to transforming pharmacy care through innovative solutions. The Product Quality Engineer III is responsible for ensuring that products meet design and regulatory requirements, leading quality initiatives, and managing product change control processes.
CommunitiesHealth CareMedicalPharmaceutical
Responsibilities
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
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
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
Qualification
Required
Bachelor's degree in Engineering or Science discipline
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
Preferred
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
Company
Omnicell Specialty Pharmacy Services
Opening or optimizing an in-house specialty pharmacy requires unique capabilities to navigate the complexities of high-cost, high-touch medications.
10001+ employees
H1B Sponsorship
Omnicell Specialty Pharmacy Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2023 (4)
2022 (3)
Funding
Current Stage
Late StageTotal Funding
$10.15M2021-12-02Acquired
2011-12-27Private Equity· $10.15M
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