Omnicell is seeking a Quality Engineer II, Document Control to lead and strengthen Document Control and the Document Management System (DMS) across multiple business units. This individual contributor role reports to the Director of Quality Assurance and partners closely with cross-functional teams.

Responsibilities

Required Knowledge & Skills:

Lead Document Control activities per Global Quality Management System processes for multiple business units.
Establish and continuously improve Document Control methods and management tools.
Ensure compliance with internal QMS documentation and FDA CFR 820, ISO 9001, and ISO 13485 as required.
Demonstrate effectiveness of Document Control activities to internal and external auditors and inspectors as required; serve as a subject matter expert.
Train and mentor internal employees on Document Control processes and relevant activities.
Establish quality metrics to demonstrate the effectiveness of the Document Control process and the DMS processes.
Knowledge of Document Management Systems.
Ability to interface with senior management, customers, consultants, vendors, and employees at all levels.
Ability to build relationships and collaborate with peers and team members.
Change agent who creates, accepts, and supports new ideas and processes.
Strong written and verbal communication and presentation skills.
Strong multitasking and time management skills.
Ability to balance urgency with diplomacy and empathy.
Ability to make decisions and execute directives.
Strong attention to detail, organization, and proje

About the role

Omnicell is seeking a Quality Engineer II, Document Control to lead and strengthen Document Control and the Document Management System (DMS) across multiple business units. This individual contributor role reports to the Director of Quality Assurance and partners closely with cross-functional teams.

Responsibilities

Required Knowledge & Skills:

Lead Document Control activities per Global Quality Management System processes for multiple business units.
Establish and continuously improve Document Control methods and management tools.
Ensure compliance with internal QMS documentation and FDA CFR 820, ISO 9001, and ISO 13485 as required.
Demonstrate effectiveness of Document Control activities to internal and external auditors and inspectors as required; serve as a subject matter expert.
Train and mentor internal employees on Document Control processes and relevant activities.
Establish quality metrics to demonstrate the effectiveness of the Document Control process and the DMS processes.
Knowledge of Document Management Systems.
Ability to interface with senior management, customers, consultants, vendors, and employees at all levels.
Ability to build relationships and collaborate with peers and team members.
Change agent who creates, accepts, and supports new ideas and processes.
Strong written and verbal communication and presentation skills.
Strong multitasking and time management skills.
Ability to balance urgency with diplomacy and empathy.
Ability to make decisions and execute directives.
Strong attention to detail, organization, and proje