Principal Medical Device Quality Engineer (JP8377))
Thousand Oaks, CA. (Remote until COVID restrictions are lifted)
Digital Health & Diagnostics Quality
6+ months (with likely extensions)
3 Key Consulting is hiring a Principal Medical Device Quality Engineer
for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Accountable to ensure quality and compliance associated with company’s software medical devices, to develop, maintain, and continuously improve the software medical device and digital health product quality capability, to ensure compliance with procedures and regulatory expectations for existing and new software medical device and digital health product programs, and to develop and optimize programs that focus on maintaining regulatory and compliance requirements while using risk-based, scalable approaches.
- 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
Top Must-Have Skill Sets:
- 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.
Day to Day Responsibilities:
- 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
Employee Value Proposition:
- 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
- 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
Compelling, active, and growing area of interest and innovation within precision medicine
Ability to gain experience from the “pharma” side of IVD and companion diagnostics
Broad exposure to many innovative IVD manufacturers
- No or minimal practical experience for IVD manufacturers
- “Consultant” view, rather than “executor” view. We need people to do actual work, not give advice on policy and strategy
- Poor communicator
We invite qualified candidates to send your resume to firstname.lastname@example.org
. 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 welcome to also share this opportunity with anyone you think might be interested in applying for this role.