Supplier Quality Engineer II

Supplier Quality Engineer (SQ Engineer II)  - 5322

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 

• Hybrid environment working out of our Warrendale, PA location (15086)
• May travel up to 30% (Including international)

COMPENSATION

• 85,000-95,000K 

• As Passionate Transformers, we find a better way to innovate relentlessly. 
• Being Mission Driven, we consistently deliver on our promises. 
• Our Entrepreneurial spirit makes the most of EVERY opportunity for innovation. 
• Understanding that Relationships Matter creates synergies that yield the greatest benefits for all.
• Intellectually Curious, eager to think deeper to learn and improve.
• In Doing the Right Thing, we lead by example in ALL we do. 

Omnicell is dedicated to fostering an inclusive workplace. We welcome applications from all individuals, valuing a wide range of perspectives and backgrounds. As an equal opportunity employer, we do not discriminate based on race, gender, religion, sexual orientation, gender identity, national origin, veteran status, or disability. We are committed to making our recruitment process accessible to everyone. We offer support and reasonable adjustments for individuals with disabilities during our hiring process. If you need assistance, please contact us at [email protected]. 

At Omnicell, respect for privacy and confidentiality is paramount. We adhere to strict policies to prevent discrimination or retaliation against those who engage in open conversations about compensation. However, employees privy to compensation information as part of their job role are expected to maintain confidentiality, except in specific circumstances outlined by law, such as during formal complaints, investigations, or as required by legal obligations.

Please note that Omnicell reserves the right to modify job roles and responsibilities as needed to meet our organization's evolving needs and drive our mission forward.