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 (<10%)
Skills Required
- Minimum 2 years experience working within a Quality Management System
- Minimum 1 year experience with metrics/data analytics and document control
- Knowledge of Document Management Systems
- Demonstrated proficiency with Microsoft Word, Excel, PowerPoint, and Project
- Ability to interface and communicate effectively with senior management, customers, vendors, and employees
- Train and mentor internal employees on Document Control processes
- Ensure compliance to QMS documentation and regulatory requirements (FDA 21 CFR 820, ISO 9001, ISO 13485)
- Establish and monitor quality metrics for Document Control and DMS processes
- Strong attention to detail, organization, project management, and multi-tasking skills
- Ability to work under tight deadlines and handle multiple detail-oriented projects
- Change agent mindset; ability to implement and support new processes
- Self-starter, analytical, decisive with strong written and presentation skills
- Bachelor's degree
- ISO 13485 and ISO 9001 hands-on experience
- eQMS experience
- Agile project management tool experience
- FDA regulated medical device experience (21 CFR 820)
Omnicell Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Omnicell and has not been reviewed or approved by Omnicell.
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Leave & Time Off Breadth — Time off offerings are described as ample, including paid sick days, family medical leave, and paid volunteer time, which supports work-life balance for many. Benefits are also indicated to begin on the first day of employment, improving immediate access to time-off related programs.
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Healthcare Strength — Health coverage is presented as comprehensive, spanning medical, dental, vision, life, and disability insurance along with mental health benefits. This breadth indicates a well-rounded healthcare package for physical and mental wellbeing.
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Wellbeing & Lifestyle Benefits — Wellbeing and lifestyle supports extend beyond core insurance through items like a fitness stipend, commuter benefits, and a remote work program. These perks broaden the overall rewards package and can improve day-to-day affordability and flexibility.
Omnicell Insights
What We Do
Since 1992, Omnicell (NASDAQ: OMCL) has been transforming the pharmacy care delivery model through the Autonomous Pharmacy, a combination of hardware, software, and services that enables providers to improve quality, reduce costs, and increase human efficiencies. Through Omnicell’s industry-leading medication management platform and portfolio of technology-enabled services, health systems and retail pharmacies are realizing how connected technology and intelligence can help solve for the most pressing challenges in medication management. Over 7,000 facilities worldwide use Omnicell automation and analytics solutions to help increase operational efficiency, reduce medication errors, deliver actionable intelligence, and improve patient safety. More than 50,000 institutional and retail pharmacies across North America and the United Kingdom leverage Omnicell's innovative medication adherence and population health solutions to improve patient engagement and adherence to prescriptions, helping to reduce costly hospital readmissions. To learn more, visit www.omnicell.com
