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.