Quality Engineer III, Internal Auditor - Cranberry, United States - Omnicell

Description

Job Description

QMS Lead Internal Auditor (Quality Engineer III)

Are you Quality professional who has experience in Internal Auditing for Quality Management Systems (QMS)? Are you looking for an exciting new opportunity? Then Omnicell has the perfect opportunity for you.

This individual contributor role will report to the Director, Quality Assurance.

Our QMS Lead Internal Auditor will be responsible for leading Omnicell's Global QMS Audit program across multiple business units, collaborating with cross-functional personnel, and for establishing metrics to demonstrate the effectiveness of our QMS Internal Audit program.

Responsibilities:
Lead and Execute QMS Internal Audit activities for multiple business units. Work with business units to identify improvement opportunities.
Facilitate External Audit activities with Notified Bodies for multiple business units.
Establish best practices, drive process and quality improvements within the QMS Audit program.

Demonstrate effectiveness of the QMS Internal Audit program to internal and external auditors and inspectors; will serve as a subject matter expert.

Mentor other auditors within the QMS Internal Audit program.
Establish quality metrics to demonstrate effectiveness of the QMS Internal Audit program.

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


Required Knowledge and Skills:
Ability to effectively interface and communicate with multiple constituents, including senior management, customers, consultants, vendors, and employees of all level
Ability to build relationships and work collaboratively with peers and team members
Change agent who creates, accepts and supports new ideas and processes
Strong written and verbal communication; as well as effective presentation skills to all levels of the organization
Refined multi-tasking and time management skills
Ability to consistently balance sense of urgency with diplomacy/empathy
Ability to make decisions and execute directives
Strong attention to detail, organization, and project management skills
Ability to work under tight deadlines and handle multiple detail-oriented projects
Self-starter, organized, analytical and decisive


Basic Qualifications:
Bachelor's degree
Minimum 3 years quality/regulatory experience
Experience in QMS internal auditing
Certified Quality Auditor (CQA) or other audit training that certifies in auditing principles


Preferred Qualifications:
ISO 13485 or FDA regulated medical device experience


Work Conditions:
Office Environment - Hybrid, as needed
Minimal travel (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.

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

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.

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