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Design Assurance Quality Engineer III - Cranberry, United States - Omnicell
Description
Job DescriptionQuality 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%
About Us
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.
About the Team
Omnicell 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 atAt 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.
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