- Hybrid, as needed May travel up to 10%About UsSince 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.
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Design Assurance Quality Engineer III - Cranberry Twp, United States - Omnicell
Description
Job DescriptionQuality Assurance Engineer III, Design AssuranceReporting to the Director or Manager of Quality Design Assurance, the Quality Design Assurance Engineer will be responsible for leading Design Assurance activities in collaboration with cross-functional personnelResponsibilities:
Participate in core team meetings and design reviews to serve as primary representative of Quality and Regulatory on the product development teams Review and approve all design verification and validation protocols, plans and records Ensure that design outputs meet the design inputs Initiate and maintain product-specific Device Master Records (DMR)
Lead the Defect Review Board for assigned products and verify acceptable resolution of design defects Ensure production equivalency is reviewed, documented and tracked as required per verification and validation protocols Serve as a key contributor in the execution of the product change control process including:
Verifying that all requested changes contain adequate information and detail Creating agendas and meeting minutes for cross-functional review and assignment of requested product changes Hosting multiple meetings throughout the change control process to ensure execution to established procedures Running queries and metrics to ensure progress of changes Ensure compliance to internal QMS documentation and ISO 9001 or ISO 13485Additional
Responsibilities:
Support the Quality Department objectives and goals by managing or participating in Quality projects Manage and/or participate in CAPAs as required Act as a liaison between Quality and other Omnicell functional departments Participate in Quality Management Review meetings, as necessaryRequired Knowledge and Skills: Ability to effectively interface and communicate with multiple constituents, including senior management and employees of all levels Change agent who accepts and supports new ideas and processes Strongly demonstrated written and verbal communication and presentation skills Refined multi-tasking and time management skills Ability to consistently balance sense of urgency with diplomacy/empathy Ability to work independently, take initiative and make decisions while executing directives Strongly demonstrated attention to detail and organizational and project management skills Demonstrated proficiency with common MS office programs (Word, Excel, PowerPoint, Project)
Basic Qualifications:
Bachelor of Science degree Minimum (3) years quality/regulatory experience or relevant design/manufacturing engineering experience Experience in product and process development Team oriented with strong communication skills Experience working in a regulated environment
Preferred Qualifications:
Minimum (5) years quality/regulatory experience ISO 13485 or FDA regulated medical device experience Experience working with complex electro-mechanical systems
Work Conditions:
Office Environment
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. In Doing the Right Thing, we lead by example in ALL we do.
We value creating an inclusive culture and a healthier world through ESG initiatives, Employee Impact Groups, learning, well-being programs, and more.
Join us in transforming the pharmacy care delivery model, making patient care safer and smarter for all.About the TeamOmnicell is dedicated to fostering a diverse and inclusive workplace. We welcome applications from all individuals, valuing a wide range of perspectives and backgrounds.
As an equal opportunity employer, we do not discriminate based on race, gender, religion, sexual orientation, gender identity, national origin, veteran status, or disability.
We are committed to making our recruitment process accessible to everyone. We offer support and reasonable adjustments for individuals with disabilities during our hiring process. If you need assistance, please contact us at At Omnicell, respect for privacy and confidentiality is paramount. We adhere to strict policies to prevent discrimination or retaliation against those who engage in open conversations about compensation.However, employees privy to compensation information as part of their job role are expected to maintain confidentiality, except in specific circumstances outlined by law, such as during formal complaints, investigations, or as required by legal obligations.
Please note that Omnicell reserves the right to modify job roles and responsibilities as needed to meet our organization's evolving needs and drive our mission forward.
