Job Information
Omnicell, Inc. Design Assurance Quality Engineer III in Cranberry Township, Pennsylvania
Quality Assurance Engineer III, Design Assurance
Reporting 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 personnel.
Responsibilities:
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 13485
Additional 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 necessary
Required 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 – Hybrid, as needed
May travel up to 10%
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.
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.
Job Identification: 2465
Job Category: Quality
Posting Date: 02/23/2024, 11:36 PM
Job Schedule: Full time
Locations: Cranberry Township, PA, United States
Job Level: Experienced
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.