Product Quality Engineer II - Omnicell
Cranberry Township, PA
About the Job
Product Quality Engineer, II
Quality team collaborates with all areas of the organization, including product management, engineering, and customer-facing teams, to ensure we consistently meet customer needs. They provide end-to-end quality support for our products and services by effectively implementing and managing our Quality Management System (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, analyzing data, and maintaining compliance with regulatory standards. The ideal candidate will be versatile, analytical, detail-oriented, with strong communication and problem-solving skills.
Responsibilities:
_Change Control and Design:_
+ Execute Defect Management and Engineering Escalation Processes
+ Review and approve design and service verification and validation protocols and reports related to product development and product changes.
+ Quality support for Omnicell’s Product Lifecycle Process
+ Lead and manage the product change control process by tracking progress through queries and metrics, and by ensuring all requested changes are thoroughly documented and adhering to procedural requirements.
+ Facilitate cross-functional change control meetings and create and distribute agendas, meeting minutes and action items.
+ Maintain the Device Master Record (DMR) throughout product release and post-market changes.
+ Ensure that design outputs align with design inputs and are compliant with established protocols.
_Field, Customer and Safety:_
+ Review, log, and triage out-of-box quality issues and potential safety concerns reported during product installation and field/customer 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 Review Meetings and drive product-specific risk management tasks and updates.
+ Support the process for Medical Device Reporting (MDR) to regulatory agencies and support the Field Action Process and Recalls.
_Compliance and Continuous Improvement:_
+ Ensure compliance with internal Quality Management System (QMS) documentation and regulatory standards such as ISO 9001 and ISO 13485.
+ Utilize quality investigation and problem-solving tools to analyze complaint trends and drive improvements.
+ Produce and review metrics related to quality processes, driving actions based on established thresholds and benchmarks.
+ Support Quality Department objectives by managing or participating in quality improvement projects.
+ Encourage the use of the Quality Management System and help create processes to enhance customer satisfaction.
+ Engage with various teams to optimize quality system records and ensure proper product document control.
Required Knowledge and Skills:
+ Ability to effectively interface and communicate with multiple constituents, including senior management and employees of all levels
+ Ability to work collaboratively with peers and team members
+ Change agent who accepts and supports new ideas and processes
+ Strong organizational and project management skills
+ Refined multi-tasking and time management skills
+ Ability to work under tight deadlines
+ Self-starter, organized, 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)
Basic Qualifications:
+ Bachelor’s degree in Engineering or Science discipline
Preferred Qualifications:
+ 1-2 years professional experience
+ Experience in product development and/or maintenance
+ Experience in process development
+ Experience working in a regulated environment (i.e. ISO 9001, ISO 13485 or FDA regulated)
+ Experience working with complex electro-mechanical systems
Work Conditions:
+ Office Environment
+ May travel up to 25%
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.
+ In Doing the Right Thing , we lead by example in ALL we do.
We value creating an inclusive culture and a healthier world through ESG initiatives, Employee Impact Groups, learning, well-being programs, and more. 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 a diverse and 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 Recruiting@omnicell.com .
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.
Job Identification: 3302
Job Category: Quality Assurance Engineering
Posting Date: 10/09/2024, 7:13 PM
Job Schedule: Full time
Locations: Cranberry Township, PA, United States
Job Level: Experienced
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.
Quality team collaborates with all areas of the organization, including product management, engineering, and customer-facing teams, to ensure we consistently meet customer needs. They provide end-to-end quality support for our products and services by effectively implementing and managing our Quality Management System (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, analyzing data, and maintaining compliance with regulatory standards. The ideal candidate will be versatile, analytical, detail-oriented, with strong communication and problem-solving skills.
Responsibilities:
_Change Control and Design:_
+ Execute Defect Management and Engineering Escalation Processes
+ Review and approve design and service verification and validation protocols and reports related to product development and product changes.
+ Quality support for Omnicell’s Product Lifecycle Process
+ Lead and manage the product change control process by tracking progress through queries and metrics, and by ensuring all requested changes are thoroughly documented and adhering to procedural requirements.
+ Facilitate cross-functional change control meetings and create and distribute agendas, meeting minutes and action items.
+ Maintain the Device Master Record (DMR) throughout product release and post-market changes.
+ Ensure that design outputs align with design inputs and are compliant with established protocols.
_Field, Customer and Safety:_
+ Review, log, and triage out-of-box quality issues and potential safety concerns reported during product installation and field/customer 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 Review Meetings and drive product-specific risk management tasks and updates.
+ Support the process for Medical Device Reporting (MDR) to regulatory agencies and support the Field Action Process and Recalls.
_Compliance and Continuous Improvement:_
+ Ensure compliance with internal Quality Management System (QMS) documentation and regulatory standards such as ISO 9001 and ISO 13485.
+ Utilize quality investigation and problem-solving tools to analyze complaint trends and drive improvements.
+ Produce and review metrics related to quality processes, driving actions based on established thresholds and benchmarks.
+ Support Quality Department objectives by managing or participating in quality improvement projects.
+ Encourage the use of the Quality Management System and help create processes to enhance customer satisfaction.
+ Engage with various teams to optimize quality system records and ensure proper product document control.
Required Knowledge and Skills:
+ Ability to effectively interface and communicate with multiple constituents, including senior management and employees of all levels
+ Ability to work collaboratively with peers and team members
+ Change agent who accepts and supports new ideas and processes
+ Strong organizational and project management skills
+ Refined multi-tasking and time management skills
+ Ability to work under tight deadlines
+ Self-starter, organized, 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)
Basic Qualifications:
+ Bachelor’s degree in Engineering or Science discipline
Preferred Qualifications:
+ 1-2 years professional experience
+ Experience in product development and/or maintenance
+ Experience in process development
+ Experience working in a regulated environment (i.e. ISO 9001, ISO 13485 or FDA regulated)
+ Experience working with complex electro-mechanical systems
Work Conditions:
+ Office Environment
+ May travel up to 25%
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.
+ In Doing the Right Thing , we lead by example in ALL we do.
We value creating an inclusive culture and a healthier world through ESG initiatives, Employee Impact Groups, learning, well-being programs, and more. 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 a diverse and 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 Recruiting@omnicell.com .
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.
Job Identification: 3302
Job Category: Quality Assurance Engineering
Posting Date: 10/09/2024, 7:13 PM
Job Schedule: Full time
Locations: Cranberry Township, PA, United States
Job Level: Experienced
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.
Source : Omnicell