Omnicell is hiring for a Quality Engineer II, Document Control to support and strengthen our Document Control and Document Management System processes. This individual contributor role reports to the Director of Quality Assurance and partners closely with cross-functional teams across multiple business units.
Responsibilities
- 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 to 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; will need to serve as a subject matter expert
- Train and mentor internal employees on Document Control processes and necessary activities
- Establish quality metrics to demonstrate effectiveness of the Document Control process and the DMS processes
Required Knowledge & Skills
- Knowledge of Document Management Systems
- Ability to effectively interface and communicate with multiple constituents, including senior management, customers, consultants, vendors, and employees of all levels
- 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
- Demonstrated proficiency with common MS office programs (Word, Excel, PowerPoint, Project)
- Ability to work under tight deadlines and handle multiple detail-oriented projects
- Self-starter, organized, analytical and decisive
Basic Qualifications
- 2 years’ minimum experience working within a Quality Management System
- 1 year minimum experience working with metrics/data analytics and document control
Preferred Qualifications
- Bachelor's degree
- ISO 13485 & 9001 experience
- Agile project management tool experience
- eQMS experience
- FDA regulated medical device experience 21CFR820
Work Conditions
Hybrid, 2-3 days in office in Cranberry Township, PAMinimal travel (
