Product Regulatory Engineer II - Omnicell
Pittsburgh, PA
About the Job
Product Regulatory Specialist II (Quality Assurance Engineer II)
Reporting to the Manager of Product Regulatory and located at the Omnicell Cranberry Woods, PA or Fort Worth, TX facility. The Quality and Regulatory Engineer will be responsible for supporting product regulatory activities.
Responsibilities:
+ Maintain and track product safety certifications related to IEC 60601 and 61010 series of standards.
+ Maintain the Applicable Standards Matrix
+ Track revisions to federal and global regulations to ensure timely compliance.
+ Identify and maintain product regulatory requirements for domestic and international products.
+ Work with global third-party distributors to maintain product regulatory compliance.
+ Provide Input on Quality/Regulatory Product Requirements for new product development projects.
+ Develop standard global processes to support product regulatory compliance activities.
+ Escalate product compliance risks with objective findings and proposed resolutions.
+ Support third party certification process for new products and product changes
+ Ensure compliance to internal QMS documentation and ISO 9001 or ISO 13485
+ Establish quality metrics to demonstrate the level of effectiveness of the regulatory process.
+ Support the Quality Department objectives and goals by managing or participating in Quality projects.
+ Manage and/or participate in CAPAs as required.
Required Knowledge and Skills:
+ Ability to work collaboratively with peers and team members.
+ Change agent who accepts and supports new ideas and processes.
+ Strongly demonstrated written and verbal communication and presentation skills
+ Refined multi-tasking and time management skills.
+ Ability to consistently balance sense of urgency with diplomacy/empathy.
+ Strongly demonstrated attention to detail
+ Commitment to cost reduction/controls.
+ 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 (1) years quality/regulatory experience or relevant design/manufacturing engineering experience
+ Experience in product regulatory certifications
Preferred Qualifications:
+ Minimum (5) years quality/regulatory experience
+ ISO 13485 or FDA regulated medical device experience.
+ Experience working with complex electro-mechanical systems.
+ Experience with global regulatory requirements for mechanical systems and testing such as UL, CSA or NTS
+ Bachelor’s degree.
Work Conditions:
+ Office Environment
+ May travel up to 10%
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: 3250
Job Category: Quality Assurance Engineering
Posting Date: 09/27/2024, 5:46 PM
Job Schedule: Full time
Locations: Pittsburgh, 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.
Reporting to the Manager of Product Regulatory and located at the Omnicell Cranberry Woods, PA or Fort Worth, TX facility. The Quality and Regulatory Engineer will be responsible for supporting product regulatory activities.
Responsibilities:
+ Maintain and track product safety certifications related to IEC 60601 and 61010 series of standards.
+ Maintain the Applicable Standards Matrix
+ Track revisions to federal and global regulations to ensure timely compliance.
+ Identify and maintain product regulatory requirements for domestic and international products.
+ Work with global third-party distributors to maintain product regulatory compliance.
+ Provide Input on Quality/Regulatory Product Requirements for new product development projects.
+ Develop standard global processes to support product regulatory compliance activities.
+ Escalate product compliance risks with objective findings and proposed resolutions.
+ Support third party certification process for new products and product changes
+ Ensure compliance to internal QMS documentation and ISO 9001 or ISO 13485
+ Establish quality metrics to demonstrate the level of effectiveness of the regulatory process.
+ Support the Quality Department objectives and goals by managing or participating in Quality projects.
+ Manage and/or participate in CAPAs as required.
Required Knowledge and Skills:
+ Ability to work collaboratively with peers and team members.
+ Change agent who accepts and supports new ideas and processes.
+ Strongly demonstrated written and verbal communication and presentation skills
+ Refined multi-tasking and time management skills.
+ Ability to consistently balance sense of urgency with diplomacy/empathy.
+ Strongly demonstrated attention to detail
+ Commitment to cost reduction/controls.
+ 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 (1) years quality/regulatory experience or relevant design/manufacturing engineering experience
+ Experience in product regulatory certifications
Preferred Qualifications:
+ Minimum (5) years quality/regulatory experience
+ ISO 13485 or FDA regulated medical device experience.
+ Experience working with complex electro-mechanical systems.
+ Experience with global regulatory requirements for mechanical systems and testing such as UL, CSA or NTS
+ Bachelor’s degree.
Work Conditions:
+ Office Environment
+ May travel up to 10%
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: 3250
Job Category: Quality Assurance Engineering
Posting Date: 09/27/2024, 5:46 PM
Job Schedule: Full time
Locations: Pittsburgh, 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