Supplier Quality Engineer (SQ Engineer II)  - 2658

Reporting to the Senior Manager of Global Supplier Quality, this individual will be based out of an Omnicell US Manufacturing Facility.  This role’s primary function is to ensure quality standards are implemented and effective throughout Omnicell’s Manufacturing and Service Supplier’s.  This 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.

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 be 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.

Additional Responsibilities: 

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.

Required Knowledge and 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. 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. Self-starter, organized, analytical and decisive.

Basic Qualifications: 

Minimum (3) years quality/manufacturing experience BS Degree in Engineering or Technical Science          

PREFERRED QUALIFICATIONS

ISO 13485 or FDA regulated medical device experience ISO 9001, ISO 14001, 21CFR820 experience Certified Lead Auditor 

WORK CONDITIONS 

Office Environment May travel up to 30% (Including international)