Product Quality Engineer II
Product Quality Engineer II
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Product Quality Engineer II
The Product Quality team partners with product management engineering and customerfacing organisations to consistently fulfil 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 analysing 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:
- Quality support for Omnicells 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 crossfunctional change control meetings.
- Maintain the OEM Device Master Record (DMR) throughout product release and postmarket changes.
- Ensure all OEM documentation is provided to the appropriate level to execute proposed changes.
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.
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 problemsolving 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 customerfacing 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 onsite 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 multitasking and time management skills
- Ability to work under tight deadlines
- Selfstarter 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 electromechanical 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)
Employment Type
Full-Time
