Product Quality Engineer II - #1675847

Job Description

Product Quality Engineer, II

The Product Quality team partners with product management, engineering, and customer-facing organisations to consistently fulfil the needs of our customers by providing end-to-end quality support for our products and services through the execution of our QMS processes.

The Product Quality Engineer at Omnicell is responsible for ensuring that our products meet all design, development, and post-market requirements. This role involves leading product change control and product development processes, analysing data, and maintaining compliance with regulatory standards. The ideal candidate will be versatile, analytical, and detail-oriented, with strong communication and problem-solving skills.

Responsibilities:

Change Control and Design:

• Quality support for Omnicell’s Product Lifecycle Process for OEM and Omnicell products
• Lead and manage the product change control process, ensuring all requested changes are thoroughly documented and detailed.
• Create and distribute agendas, meeting minutes, and action items for cross-functional change control meetings.
• Maintain the OEM Device Master Record (DMR) throughout product release and post-market changes.
• Ensure all OEM documentation is provided to the appropriate level to execute proposed changes.
  
  
  

Field, Customer and Safety:

• Review, log, and triage out-of-box quality issues and potential safety concerns reported during product installation and use.
• Collaborate with cross-functional teams to address quality and safety issues promptly and effectively by investigating potential safety concerns and performing post-production safety risk assessments as applicable.
• Participate in Safety Risk Management Board Meetings and drive product-specific risk management tasks and updates.
  
  
  

Compliance and Continuous Improvement:

• Ensure compliance with internal Quality Management System (QMS) documentation and regulatory standards such as ISO 9001 and ISO 13485.
• Utilise quality investigation and problem-solving tools to analyse complaint trends and drive improvements.
• Produce and review metrics related to quality processes, driving actions based on established thresholds and benchmarks.
• Encourage the use of the Quality Management System and create processes to enhance customer-facing activities.
• Engage with various teams to optimise quality system records and ensure proper product document control.
  
  
  

Supplier Management:

• Directly support the Supplier Quality team through on-site audits of both Suppliers and OEMs
• Prepare audit plans and audit reports for Supplier and OEMs
• Prepare metrics for International and North American leadership teams related to Supplier Performance
• Support Business Partner assessments and developments, as necessary
• Prepare, submit and manage Supplier Corrective Action Requests (SCARs)
• Support Product Lifecycle Process (PLP) projects, acting as a Supplier Quality representative
  
  
  

Required Knowledge and Skills:

• Understanding of Quality Management System structure
• Understanding of Supplier Management
• Understanding of OEM Management
• Ability to effectively interface and communicate with multiple constituents, including senior management and employees of all levels
• Understanding of Engineering drawings, including schematic and technical
• Ability to work collaboratively with peers and team members
• Strong organisational and project management skills
• Refined multi-tasking and time management skills
• Ability to work under tight deadlines
• Self-starter, organised, analytical and decisive
• Strong written and verbal communication and presentation skills
• Ability to consistently balance sense of urgency with diplomacy/empathy
• Ability to make decisions and execute directives
• Demonstrated proficiency with common MS office programs (Word, Excel, PowerPoint, Project)
  
  
  

Professional Experience:

• Experience working in a regulated environment (i.e. ISO 9001, ISO 13485 or FDA regulated)
• Experience in product development and/or maintenance
• Experience in process development
• Experience working with complex electro-mechanical systems
  
  
  

Work Conditions:

• Hybrid Environment (office/customer/supplier site presence as required by business needs)
• May travel up to 20% (includes both Domestic and International travel)
  
  
  

About Us

Since 1992, Omnicell has been committed to transforming pharmacy care through outcomes-centric innovation designed to optimize clinical and business outcomes across all settings of care. We strive to be the healthcare provider’s most trusted partner by our guiding promise of “Outcomes. Defined and Delivered.”  

Our comprehensive portfolio of robotics, smart devices, intelligent software, and expert services is helping healthcare facilities worldwide to improve business and clinical outcomes as they move closer to the industry vision of the Autonomous Pharmacy. 

Our guiding principles inform everything we do: 

• 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. 
  
  
  

We are deeply committed to Environmental, Social, and Governance (ESG) initiatives. Our ESG efforts focus on creating an inclusive culture and a healthier world. This includes our Employee Impact Groups, which foster inclusion and belonging, as well as our learning and well-being programs that support personal and professional growth. We also prioritize sustainability in our operations, aiming to reduce our environmental footprint and promote responsible business practices. Join us in transforming the pharmacy care delivery model, making patient care safer and smarter for all.

About The Team

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.