Job Information
Omnicell Quality Assurance Engineer II in Pittsburgh, Pennsylvania
Job Title: Quality Engineer II, CAPA
The Quality Engineer II, CAPA will report to the CAPA Manager and will be responsible for leading CAPA activities from initiation to closure.
The Quality Engineer II, CAPA, will report to the CAPA Manager and will be responsible for facilitating the CAPA program to solve complex business problems affecting Omnicell’s customers.
Responsibilities:
Facilitate timely and effective completion of activities throughout the CAPA lifecycle including, but not limited to:
Collaborate with issue identifiers to clarify information associated with newly opened Corrective Action Requests (evaluate issue descriptions for objectivity, risk, appropriate data and records, etc.)
Organize and lead Corrective Action Board (CAB) meetings, prepare accurate meeting records
Work with CAPA Owners and Subject Matter Experts to elicit information and investigate issues, lead application of problem-solving tools
Conduct training on CAPA and Root Cause Analysis
Guide development of targeted action plans and effectiveness checks
Ensure appropriate objective evidence is included in CAPA records
Screen results of completed activities prior to CAB meetings
Analyze quality data and apply statistical techniques to identify existing and potential causes of non-conformances
Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement
Ensure CAPA documents/records are compliant with applicable regulations and standards
Assist with educating employees on the CAPA process
Support Global Quality assurance activities related to Internal Audit, QMS training, or document control
Conduct internal audits as needed
Required Knowledge and Skills:
Ability to work collaboratively with peers and team members; and to effectively interact with and influence employees on all levels
Strong Project Management skills, including ability to project manage all CAPA activities
Knowledge of tools and techniques required to perform thorough root cause analysis investigations
Able to understand and analyze complex problems, including software and hardware design issue.
Ability to analyze data and apply statistical techniques
Proficiency with common MS office programs (Word, Excel, PowerPoint, Project)
Strong understanding of applicable regulations and standards such as 21 CFR Part 820, ISO 13485, and ISO 9001
Basic Qualifications:
Bachelor’s degree
3 years of Quality Management Systems experience
Preferred Qualifications:
ISO 9001, ISO13485 or FDA regulated medical device experience
Bachelor’s degree in a STEM field
3 years of direct CAPA and/or Quality Assurance experience
Lean six sigma certification
Audit certification
Work Conditions
Hybrid WFH/Office Environment
Potential Occasional Travel
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.
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 at Recruiting@omnicell.com .
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.
Job Identification: 3269
Job Category: Quality Assurance Engineering
Posting Date: 09/20/2024, 2:11 PM
Job Schedule: Full time
Locations: Pittsburgh, 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.