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).
- Understanding of software development lifecycle (SDLC) and experience in defect tracking platforms like Jira
- 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
- 5+ years in Engineering, Quality or related technical 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 QMSR)
Preferred Qualifications:
- Experience working with complex electro-mechanical systems
- Experience working with Cloud software and AI/ML
Work Conditions:
- Office Environment
- May travel up to 25%
Since 1992, Omnicell has been committed to transforming pharmacy care through outcomes-centric innovation designed to optimize clinical and business outcomes across all settings of care. We strive to be the healthcare provider's most trusted partner by our guiding promise of "Outcomes. Defined and Delivered."
Our comprehensive portfolio of robotics, smart devices, intelligent software, and expert services is helping healthcare facilities worldwide to improve business and clinical outcomes as they move closer to the industry vision of the Autonomous Pharmacy.
Our guiding principles inform everything we do:
- As Passionate Transformers, we find a better way to innovate relentlessly.
- Being Mission Driven, we consistently deliver on our promises.
- Our Entrepreneurial spirit makes the most of EVERY opportunity for innovation.
- Understanding that Relationships Matter creates synergies that yield the greatest benefits for all.
- Intellectually Curious, eager to think deeper to learn and improve.
- In Doing the Right Thing, we lead by example in ALL we do.
We are deeply committed to Environmental, Social, and Governance (ESG) initiatives. Our ESG efforts focus on creating an inclusive culture and a healthier world. This includes our Employee Impact Groups, which foster inclusion and belonging, as well as our learning and well-being programs that support personal and professional growth. We also prioritize sustainability in our operations, aiming to reduce our environmental footprint and promote responsible business practices. Join us in transforming the pharmacy care delivery model, making patient care safer and smarter for all.