Principal Engineer (JP4678)

Location: Thousand Oaks, ca
Date Posted: 09-07-2018
Job Title: Principal Engineer (JP4678)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit: Device Quality
Duration: 2+ years (likely extensions)
 
3Key Consulting Inc. is recruiting for a Principal Engineer with 7-10 years’ experience in quality or operations experience, design control and medical device/drug development for a global, CA-based, bio-pharmaceutical company.
 
Job Description:
As a member of Amgen's Commercial Quality group for drug delivery systems, this position will provide Quality engineering support for new product development and ensure design control systems are followed in the creation of new drug delivery devices.  Responsibilities include:
 
  • Participation in Design development.
  • Design control per FDA CFR 820.30. 
  • Corrective and preventive action projects.
  • Documentation related to investigation of product complaints, trending of quality data, and other assignments as given.
 
With general guidance, consultant will work with process development and operations to ensure robust designs are verified, validated, qualified and launched. In addition to new development the responsibilities will include working on cross functional teams to understand product inquiries, reduce complaint rates and provide support for troubleshooting operational issues and capital projects.  Consultant will develop, organize, analyze, present and implement results for operational issues or engineering projects of moderate scope and complexity.
 
Consultant must have experience with quality systems and ISO 13485 or FDA CFR 820.30 related compliance regulations and management of engineering development procedures.
 
Top Must-Have Skill Sets:
  • Understanding of design controls.
  • Understanding of CAPA/NC and relevant procedures (3) Quality engineer be able to work with minimal.
  • Oversight, critical thinking.
  • Experience with electromechanical devices and device development.
 
Day to Day Responsibilities/first 30 Days:
  • Training, work on Pre-filled syringes and mechanical and electromechanical devices (medical device perspective) and support process/procedure remediation effort.
  • Support change controls, complaint investigation efforts, design and system improvements.
 
Basic Qualifications:
  • BA/BS in Science, Engineering, or related field.
  • 7-10+ years of Quality or Operations experience in the pharmaceutical or medical device industry with progressively increasing responsibility and demonstrated experience in design verification, design validation, investigations and/or change control.
 
Preferred Qualifications:
  • Experience with product design enhancements/improvements.
  • Experience in interacting with regulatory agencies.
  • Good written and verbal communication skills.
  • Ability to interpret and apply regulatory and quality requirements.
  • Ability to work independently as well as on teams.
  • Ability to prioritize and manage multiple tasks.
  • Ability to work in a challenging and fast-paced work environment.
 
Employee Value Proposition:
Position will support device quality for exposure to drug device combination products. This is very hot item/fast growing industry for medical devices. Position has potential to even become full time depending on Amgen business growth.
 
Red Flags:
No resume with drug experience only. It should be drug and device or only device experience.
 
Interview process:
Phone interview then panel F2F for viable candidates.
 
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. You are also welcome to share this posting with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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