Sr. Supplier Quality Engineer

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)