Quality Engineer III, Internal Auditor

2 weeks ago

Cranberry Township, United States Omnicell, Inc Full time

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%)

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