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Senior Quality Engineer, Biopharma/Digital Health - Remote (JP10050)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Senior Quality Engineer, Biopharma/Digital Health - Remote (JP10050)
Location: Thousand Oaks, CA (Remote work) 
Employment Type:  Contract
Business Unit: 
Digital Health & Diagnostics Quality
Duration: 6+ Months with likely extensions
Notes:  Remote. Must have device design experience. This is a senior level role. Pre-screening questionnaire will apply for submission to client.
Posting Date:  04/04/2022

3 Key Consulting is hiring a Senior Quality Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:

Accountable to ensure quality and compliance associated with Amgen 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.

Key Responsibilities:
  • 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
  • Authority:
    • 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
Basic Qualifications:
• 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

Why is the Position Open?
Staff augmentation

Top Must-Have Skill Sets:
  • 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

Day to Day Responsibilities:
  • 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
  • Assist with 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

Employee Value Proposition:
To work with a dynamic team

Red Flags:
  • “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

Interview process:
phone /webex

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com.  If you decide that you’re not interested in pursuing this 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.

3KC Talent Acquisition Team
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