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Job Description
Sr. Supplier Quality Engineer Omnicell - 3.4 Warrendale, PA Job Details 3 days ago Qualifications Mechanical blueprint interpretation Communication with suppliers Project management in manufacturing Manufacturing facility Medical device manufacturing facility experience Following blueprint specifications Project management software Biomedical regulatory compliance Presentation creation Managing projects Productivity software Data analysis software Full Job Description Description This Supplier Quality Assurance Engineer III will be based out of one of Omnicell's US Manufacturing Facility - located in Cranberry Township, PA. This is a senior position with high visibility and impact. This role's primary function is to ensure quality standards are implemented and effective throughout Omnicell's international Manufacturing and Service supply base with an additional focus on New Product Introductions. This SQ department member will work closely with Global Supply Chain, Manufacturing Engineering personnel at Omnicell to understand current product quality issues and assist with root cause and corrective action with suppliers.
Responsibilities:
Lead Supplier Design for Manufacturability discussions with support from internal engineering teams. Manage supplier qualifications for both NPI and sustaining engineering changes. Lead in the development of Supplier
IQ/OQ/PQ
Protocols and Final Reports, ensuring sampling sizes are statistically valid. Guide suppliers to establish and maintain controlled manufacturing processes utilizing Control Plans, PFMEA's, and Statistical Process Control. Lead SCAR activities for supplier product and process quality issues, ensuring all facets of CAPA activities are addressed including effectiveness. Plan and execute supplier audits to ensure performance to Omnicell quality standards and regulatory requirements are being met. Data collection, analysis, and trending of supplier performance data from ERP system and PLM database. Creation of metric reports and presentations for Internal, Supplier QBRs and Management Review. Develop, communicate & implement strategies for improving performance of Omnicell's Manufacturing & Service suppliers. Work closely with other QA departments within the Omnicell Global Factory Network on assigning and monitoring effectiveness of Supplier Corrective Actions in a timely manner.
Additional Responsibilities:
Act as a change agent who accepts and supports new ideas and processes. Commitment to cost reduction/controls. Lead the on-going maintenance and continual improvement of Supplier Quality processes. Update/creation of internal procedures as required. Participate in corporate quality improvement projects as required.
Required Knowledge and Skills:
Proven working knowledge of auditing methodologies associated with ISO 9001 and
ISO 13485
standards. Quality concepts/tools (Pareto, fishbone diagram, FMEA, etc.). Proficient understanding of engineering and manufacturing terminology and processes such as sheet metal forming, injection molding, die casting, PCB manufacturing, SMT, Thermoforming, Reaction Molding. Self-starter with the ability to own projects and tasks to ensure timely execution from start to finish. Excellent comprehension of engineering drawings and specifications. Proactive, self-motivated, and empathetic work ethic in a fast-paced work environment. Ability to effectively interface and communicate with multiple constituents, including senior management, suppliers, consultants, and employees of all levels. 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. 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.
Basic Qualifications:
Minimum (5) years quality/manufacturing experience BS Degree in Engineering or Technical Science ISO 13485 or FDA regulated medical device experience
Preferred Qualifications:
ISO 13485 and
ISO 9001
Certified Lead Auditor from accredited body
ISO 9001, ISO 14001, 21CFR820
experience Six-Sigma Green Belt or higher Demonstrated knowledge in sheet metal forming and/or injection molding
Work Conditions:
Office Environment May travel up to 30% (including international) EEO, Privacy, and Adaptability Omnicell welcomes applications from all individuals, valuing a wide range of perspectives and backgrounds. As an equal opportunity employer, we do not discriminate based on race, gender, religion, sexual orientation, gender identity, national origin, veteran status, or disability. We are committed to making our recruitment process accessible to everyone. We offer support and reasonable adjustments for individuals with disabilities during our hiring process. If you need assistance, please contact us at . At Omnicell, respect for privacy and confidentiality is paramount. We adhere to strict policies to prevent discrimination or retaliation against those who engage in open conversations about compensation. However, employees privy to compensation information as part of their job role are expected to maintain confidentiality, except in specific circumstances outlined by law, such as during formal complaints, investigations, or as required by legal obligations. Learn more about our privacy practices: https://www.omnicell.com/privacy/ Please note that Omnicell reserves the right to modify job roles and responsibilities as needed to meet our organization's evolving needs and drive our mission forward. About Us At Omnicell, innovation starts with people who are passionate about making healthcare safer and smarter. Since 1992, we've been transforming the future of pharmacy care through bold ideas and hands-on solutions that make a real impact on clinicians and patients' lives. We build outcomes-driven technology—from robotics to intelligent software—that helps clinicians work more efficiently and ensures patients get the care they need. Every improvement, every breakthrough, every idea is rooted in our belief that better is always possible. But what sets us apart isn't just the work we do, it's how we do it. Our Culture of Care shapes everything, from how we show up for each other to how we solve tough problems together. You'll find a team that has your back, leaders who listen, and a shared commitment to building something that matters. Here, careers are more than job titles, they are journeys of purpose and possibility. Whether you're just getting started or ready to grow in new directions, we'll meet you where you are, with support, flexibility, and opportunity that matches your ambition. If you're driven by purpose and ready to shape what's next in healthcare, there's a place for you at Omnicell.
