Sr. Supplier Quality Engineer

Omnicell; Pittsburgh (Allegheny County); On-site; USD 110,000 - 150,000; Full time

Job summary

Omnicell is seeking a Senior Supplier Quality Assurance Engineer III based in Cranberry Township, PA to ensure quality standards across Omnicell’s global manufacturing and service supply base, with a focus on new product introductions. The role collaborates with Global Supply Chain and Manufacturing Engineering to address quality issues and drive corrective actions with suppliers.

The position requires leading supplier audits, developing IQ/OQ/PQ protocols, and driving CAPA effectiveness within

Qualifications

• Minimum five years of quality/manufacturing experience.
• BS Degree in Engineering or Technical Science.
• ISO 13485 or FDA regulated medical device experience.
• Lead Auditor experience for ISO13485 / ISO9001 (preferred).
• Experience with ISO 9001, ISO 14001, and 21CFR820 (preferred).
• Six‑Sigma Green Belt or higher (preferred).
• Knowledge of sheet metal forming and/or injection molding (preferred).

Responsibilities

• Lead supplier design for manufacturability discussions with internal engineering teams.
• Manage supplier qualifications for NPI and sustaining engineering changes.
• Develop IQ/OQ/PQ protocols and final reports with statistically valid sample sizes.
• Guide suppliers to establish controlled processes using Control Plans, PFMEAs, and SPC.
• Lead SCAR activities and CAPA effectiveness across supplier issues.
• Plan and execute supplier audits to meet Omnicell quality standards and regulatory requirements.
• Collect, analyze, and trend supplier performance data from ERP and PLM.
• Create metric reports and presentations for internal, Supplier QBRs, and Management Review.
• Develop and implement strategies to improve supplier manufacturing/service performance.
• Collaborate with QA to monitor effectiveness of Supplier Corrective Actions.

Skills

Auditing methodologies (ISO 9001 / ISO

Education

BS Degree in Engineering or Technical Science

Tools

MS Office

ERP systems

PLM database

Job 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. The 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. The 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, PFMEAs, 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.
• Collect, analyze, and trend supplier performance data from ERP system and PLM database.
• Create metric reports and presentations for Internal, Supplier QBRs and Management Review.
• Develop, communicate and 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.
• Commit to cost reduction and controls.
• Lead ongoing maintenance and continual improvement of Supplier Quality processes.
• Update or create 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.
• Knowledge of quality concepts/tools such as Pareto, fishbone diagram, and FMEA.
• Proficient understanding of engineering and manufacturing terminology and processes such as sheet metal forming, injection molding, die casting, PCB manufacturing, SMT, thermoforming, and reaction molding.
• Self‑starter with the ability to own projects and tasks to ensure timely execution.
• Excellent comprehension of engineering drawings and specifications.
• Proactive, self‑motivated, and empathetic work ethic in a fast‑paced environment.
• Ability to effectively interface and communicate with multiple constituents, including senior management, suppliers, consultants, and employees at all levels.
• Ability to work collaboratively with peers and team members.
• Strong written and verbal communication and presentation skills to all levels of an organization.
• Strong multitasking and time‑management skills.
• Strong attention to detail.
• Strong organizational and project‑management skills.
• 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 five years of 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.
• Experience with ISO 9001, ISO 14001, and 21CFR820.
• 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).