Quality Engineer II

RXinsider LTD.; Cranberry Township (Butler County); Hybrid; USD 75,000 - 95,000; Full time

Job summary

Omnicell is seeking a Quality Engineer II, Document Control to strengthen our Document Control and Document Management System processes. You will report to the Director of Quality Assurance and partner with cross-functional teams across business units.

Responsibilities include leading Document Control activities, improving methods and tools, ensuring compliance with FDA CFR 820 and ISO standards, and training staff. You will interact with auditors and drive metrics for DMS effectiveness.

Qualifications

• Knowledge of Document Management Systems and QMS.
• Experience interfacing with senior management and external auditors.
• Bachelor's degree required; ISO 13485/9001 experience preferred.

Responsibilities

• Lead Document Control activities across multiple units per QMS.
• Establish and improve document control methods and tools.
• Ensure compliance with FDA CFR 820, ISO 9001, ISO 13485 as required.
• Demonstrate effectiveness to internal and external auditors/inspectors.
• Train and mentor staff on Document Control processes.
• Establish quality metrics for DMS and documentation processes.

Skills

Document Management Systems

Stakeholder communication

Relationship building

Change agent

Verbal & written communication

Time management

Decision making

Attention to detail

MS Office suite

Multi-project management

Self-starter

Analytical

Decisive

Education

Bachelor's degree

Tools

eQMS

Agile PM tools

Job description

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, PA minimal travel (