Product Quality Engineer II
Product Quality Engineer II
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Salary Not Disclosed
1 Vacancy
Job Description
The Product Quality team partners with product management engineering and customerfacing organizations to consistently fulfill the needs of our customers by providing endtoend 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 postmarket 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 and detailoriented with strong communication and problemsolving skills.
Responsibilities:
Change Control and Design:
- Execute Defect Management and Engineering Escalation Processes
- Review and approve design and service verification and validation protocols plans and records related to product development and product changes.
- Quality support for Omnicells Product Lifecycle Process
- 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 crossfunctional change control meetings.
- Facilitate meetings throughout the change control process to ensure adherence to procedures and track progress through queries and metrics.
- Maintain the Device Master Record (DMR) throughout product release and postmarket changes.
- Ensure that design outputs align with design inputs and are compliant with established protocols.
Field Customer and Safety:
- Review log and triage outofbox quality issues and potential safety concerns reported during product installation and use.
- Collaborate with crossfunctional teams to address quality and safety issues promptly and effectively by investigating potential safety concerns and performing postproduction safety risk assessments as applicable.
- Participate in Safety Risk Management Board Meetings and drive productspecific risk management tasks and updates.
- Drive the process for Medical Device Reporting (MDR) to regulatory agencies and manage 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 problemsolving 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 create processes to enhance customerfacing activities.
- 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
- Strong organizational and project management skills
- Refined multitasking and time management skills
- Ability to work under tight deadlines
- Selfstarter 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:
- Bachelors degree in Engineering or Science discipline
Preferred Qualifications:
- 12 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 electromechanical systems
Work Conditions:
- Office Environment
- May travel up to 25%
Employment Type
Full-Time
