2 Jobs in Thousand Oaks, CA
3 Key Consulting is Hiring a Principal Quality Engineer - (JP10260) Near Thousand Oaks, CA
- Benchmark with industry regarding quality and compliance models for software medical devices and digital health products
- Accommodate Agile software development methodology
- Ensure inspection readiness and maintain CE marks for existing software medical devices
- Train and mentor relevant staff for development and succession planning
- Maintain and resource program and project quality support portfolio
- Collaborate with Senior Management, data management and presentation, provide backup support to other Quality focus areas
- Work in partnership with the DH&DQ Leadership to develop business plans that cultivate staff development and supports the direction of the business
- Plan and lead all aspects of major change efforts in the digital health space
- Assure that current regulatory trends are accommodated in the capability
- Advise software medical device and digital health product teams as Quality representative
- Review and approve medical device design control and post-commercial documentation (internally and at times, externally)
- Interface with regulators and Notified Bodies
- Review and approve procedures and work instructions
- Doctorate degree and 2 of professional experience Program Management, Operational Excellence, Quality, R&D, Production OR
- Master’s degree and 6 years of professional experience Program Management, Operational Excellence, Quality, R&D, Production OR
- Bachelor’s degree and 8 years of professional experience Program Management, Operational Excellence, Quality, R&D, Production OR
- Associate’s degree and 10 years of professional experience Program Management, Operational Excellence, Quality, R&D, Production OR
- High school diploma / GED and 12 years of professional experience Program Management, Operational Excellence, Quality, R&D, Production
- Start to finish experience with digital devices, health technology, products, mobile medical apps,
- Deep experience with software medical device quality and compliance concepts
- Strong project management skills / ability to lead and/or lead all aspects of numerous projects simultaneously
- Represent Quality on cross-functional digital health and software medical device program/project teams. Guide teams and ensure design controls and other regulatory/procedural requirements are met.
- Manage (or perform) audits / inspections / quality agreements (purchasing controls)
- Participate in design reviews held by device manufacturers
- Participate in supplier selection activities
- Participate in project technical team meetings
- “Consultant” view, rather than “executor” view. We need people to do actual work, not give advice on policy and strategy
- Poor communicator
- Lacks the skills indicated on resume
Phone screening followed by in-person interview.We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Job Summary
Full Time
Business Services
$129k-162k (estimate)
12/13/2023
06/15/2024
3keyconsulting.com
WEST HILLS, CA
100 - 200
2009
Private
$50M - $200M
Business Services
Related Companies
The job skills required for Principal Quality Engineer - (JP10260) include Product Quality, Leadership, Project Management, etc. Having related job skills and expertise will give you an advantage when applying to be a Principal Quality Engineer - (JP10260). That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Principal Quality Engineer - (JP10260). Select any job title you are interested in and start to search job requirements.
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