Supplier Quality Engineer II

About the role

Reporting to the Senior Manager of Global Supplier Quality, this individual will be based out of an Omnicell US Manufacturing Facility. The role’s primary function is to ensure quality standards are implemented and effective throughout Omnicell’s Manufacturing and Service Suppliers. The SQE department member will also closely work with Global Supply Chain, Development and Manufacturing Engineering personnel at Omnicell to understand current product quality issues and assist with root cause and corrective action with suppliers. The position is hybrid, located in Warrendale, PA (15086), may require up to 30% travel (including international), and requires a drug screen.

Responsibilities

• 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.
• Lead SCAR activities for supplier product and process quality issues, ensuring all facets of CAPA activities are addressed including effectiveness.
• Work with existing and new suppliers by planning and executing audits to ensure performance to Omnicell quality standards and regulatory requirements are met.
• Ability to develop, communicate & implement strategies for improving performance of Omnicell’s Manufacturing & Service suppliers.
• Partner with New Product Introduction teams to support successful component qualifications at 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.
• Provides supplier quality support of Omnicell’s suppliers engaged in the production of components.
• Review and approve Supplier IQ/OQ/PQ Protocols and Final Reports, verifying that sampling sizes are statistically valid.
• Work with suppliers to establish and maintain controlled manufacturing processes utilizing Control Plans and PFMEA’s and PPAPS.
• Act as a change agent who accepts and supports new ideas and processes.
• Commitment to cost reduction/controls.
• Support the ongoing maintenance and continual improvement of Supplier Quality processes.
• Update/creation of internal procedures as required.
• Participate in corporate quality improvement projects as required.

Skills

• Proven working knowledge of auditing methodologies associated with ISO 9001 or ISO 13485 standards.
• Quality concepts/tools (Pareto, fishbone diagram, FMEA, PPAP, etc.).
• Proficient understanding of engineering and manufacturing terminology and processes.
• 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.