Job Abstract

Supplier Quality Assurance Engineer, IV

Reporting to the Sr. Manager, Global Supplier Quality and based out of an Omnicell manufacturing facility in the U.S., this role’s primary function is to ensure quality standards are implemented and effective at Omnicell’s Contract Manufacturing and OEM Suppliers. The Supplier Quality (QA) 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 analysis and corrective action at suppliers.

Responsibilities:

• Data collection, analysis, and trending of supplier performance data from ERP system and PLM database.
• Creation of metric reports and presentations to support internal supplier QBR’s and the Omnicell Management Review process.
• 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.
• Develop, communicate & implement strategies for improving performance of Omnicell’s Contract Manufacturers & OEM suppliers.
• Partner with New Product Introduction teams to support successful Product launches 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.
• Provide supplier quality leadership in the management of Omnicell’s contract manufacturers and OEM suppliers engaged in the production of products.
• Lead in the development 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 & PFMEA’s.

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 or ISO 13485 standards.
• Quality concepts/tools (Pareto, fishbone diagram, FMEA, 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:

• BS Degree in Engineering or Technical Science.
• Minimum ten (10) years quality/manufacturing experience.
• Minimum seven (7) years of Supplier Quality experience in a medical device, healthcare technology and/or manufacturing industry.
• Certified Lead Auditor.

Preferred Qualifications:

• ISO 13485 or FDA regulated medical device experience.
• ISO 9001, ISO 14001, 21CFR820 experience.

Work Conditions:

• Office Environment.
• May travel up to 40% (Including international).

Base compensation salary range: $120,000-150,000

(Actual compensation is subject to variation due to such factors as locations, education, experience, and skillset. Learn more about our benefits at www.omnicellbenefits.com )