Quality Engineer IV

Job Summary:
Reporting to the Director, Quality Operations and located at the Omnicell Thornhill facility located in Warrendale, PA, the Quality Assurance Engineer IV will be responsible for Production Quality activities.  Their primary responsibilities will be to lead manufacturing and quality engineers to ensure quality standards are implemented within Omnicell’s manufacturing plant.  Additional responsibilities include preparation and maintenance of necessary documentation, monitor production quality performance to identify opportunities for improvements and act as prime consultant on large projects that affect the organization’s long-term goals and objectives. 

Responsibilities

• Lead projects related to manufacturing continuous improvements
• Assist in the establishment of quality acceptance criteria and activities including but not limited to incoming, in-process and final inspection
• Participate as Material Review Board member to assist in disposition of non-conforming materials
• Work with manufacturing to document, markup, and communicate changes to parts and assemblies within change control process
• Collaborate with design quality and engineering personnel to determine critical part features and review manufacturability of design 
• Participate in change control activities 
• Lead in the support of new product introductions to ensure QMS requirements are followed, including Process Verification and Validation activities and pFMEAs
• Ensure compliance to internal QMS documentation and ISO 13485
• Act as a change agent who accepts and supports new ideas and processes
• Manage and/or participate in CAPAs as required
• Act as a liaison between Quality and other Omnicell functional departments
• Update/creation of internal procedures, as required
• Lead or participate in Quality Management Review meetings

Knowledge and Skills

• Quality concepts/tools (Pareto, fishbone diagram, FMEA, etc.)
• Understanding of engineering drawings and specifications
• Ability to effectively interface and communicate with multiple constituents, including senior management, customers, consultants, suppliers, and employees of all level
• Ability to work collaboratively with peers and team members
• Strongly demonstrated written and verbal communication and presentation skills to all levels of an 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
• Strongly demonstrated attention to detail
• Commitment to cost reduction/controls
• Strongly demonstrated organizational 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
• Team builder, self-starter, organized, analytical and decisive

Basic Qualifications

• Bachelor degree in Engineering or Science or Quality management discipline
• Minimum six (6) years’ experience in a quality/manufacturing environment
• Experience working with complex electro-mechanical systems
• Experience with broad variety of measurement and quality data analytic techniques

Preferred Qualifications

• ISO 13485 or FDA regulated medical device experience
• Robotics experience
• SAP experience

Work Conditions

• Office Environment
• May travel up to 10%

Additional Requirements

• Legally authorized to work in the United States without Omnicell sponsorship now or in the future 
• Ability to pass background and employment verification checks
• Able to work from assigned location without housing or relocation assistance from Omnicell 

Since 1992, Omnicell has been committed to transforming pharmacy care through outcomes-centric innovation designed to optimize clinical and business outcomes across all settings of care. We strive to be the healthcare provider’s most trusted partner by