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Principal Compliance Engineer (JP7353)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Principal Compliance Engineer (JP7353)
Location: Thousand Oaks, CA. (Remote until COVID restrictions are lifted)
Employment Type:  Contract
Business Unit: Final Product Technologies Development
Duration: 6+ months (with likely extensions)
Posting Date: 6/5/20
 
 
3 Key Consulting is hiring a Principal Compliance Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.
 
Job Description:
Senior level position that is responsible for the quality oversight of design control, process controls, and risk management activities for combination products.  This individual will work closely with the device development teams and medical device suppliers and testing partners during the device design/development phases with supportive
responsibilities throughout the device lifecycle.  Key components of the job function include:
  • Lead Quality Engineering guidance and oversight for medical device and combination products, all phases of design control, risk management, human factor/usability engineering, process development, as well as lifecycle management during design changes.
  • Work with the device combination team to define critical to quality characteristics for device components and finished devices.
  • Lead Quality review and approval of all technical documentation for design and development technical and risk management documentation, e.g., planning, traceability matrix, protocols, reports, risk assessments, testing, etc. through applying applicable company procedures and regulatory requirements.
  • Provide input to process manufacturing design and design transfer to ensure compliant, robust product realization.
  • Support Project Team and strategy for developing and implementing changes through authoring and/or reviewing sections of documentation applicable to design control, risk management and specification and supporting responses to regulatory questions, and/or leading the Quality sub-team.
  • Support the timely handling of investigations, impact assessment, deviations, and CAPAs, and technical matters (i.e. design changes, verification, etc.) with impact to design control and risk management or related supply chain operations.
 
Why is the Position Open?
Planned Project.
 
Top Must-Have Skill Sets:
 
  • Hands-on Expertise in QMS & all phases of design control, process control & risk management.
  • Medical Device and/or combination product development experience.
  • Experience in working with medical device suppliers and testing partners on process manufacturing design & design transfer.
 
Day to Day Responsibilities:
  • Provide Quality Engineering guidance and oversight for medical device and combination products, all phases of design control, risk management, human factor/usability engineering, process development, as well as lifecycle management during design changes.
  • Work with the device combination team to define critical to quality characteristics for device components and finished devices.
  • Lead Quality review and approval of all technical documentation for design and development technical and risk management documentation, e.g., planning, traceability matrix, protocols, reports, risk assessments, testing, etc. through applying applicable company procedures and regulatory requirements.
  • Provide input to process manufacturing design and design transfer to ensure compliant, robust product realization.
  • Support Project Team and strategy for developing and implementing changes through authoring and/or reviewing sections of documentation applicable to design control, risk management and specification and supporting responses to regulatory questions, and/or leading the Quality subteam.
  • Support the timely handling of investigations, impact assessment, deviations, and CAPAs, and technical matters (i.e. design changes, verification, etc.) with impact to design control and risk management or related supply chain operations.
 
Employee Value Proposition:
Support E2E Control Strategies workstream.
 
Red Flags:
  • Short engagements.
  • Not hands-on.
 
Interview process:
Group video call.
 
 
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.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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