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89e08fdf3427778a54d5d1d58ace4361

Senior Quality Engineer

Collabera Thousand Oaks, CA Contractor
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Responsibilities:

  • Work cross-functionally and globally with individuals and project teams within Final Product Technologies Quality and the Final Product Technologies Engineering groups and their stakeholders in Marketing, Operations, and Development
  • Ensure compliance to design controls and fulfillment of user needs during test or inspection method development or design changes, including proper and compliant integration of different subsystems as required.
  • Provide quality oversight and guidance regarding the development of process control plans and implementation of process improvements/changes.
  • Work with cross-functional teams to develop, qualify, and transfer physical test or inspection methods.
  • Provide comprehensive quality guidance and advice to counterparts and stakeholders.

 Skills:

  • BS or BE in Engineering and previous experience in the medical device and/or pharmaceutical industries
  • 8 years current experience with engineering processes/procedures and quality tools.
  • Major contributions to or the leadership of projects from development through the 510k and PMA approval process.
  • Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification/validation, DOE/SPC process optimization & validation (IQ, OQ, PQ), P/DFMEA. - Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
  • Experience in test or inspection method design and development
  • Small scale device assembly and/or benchtop testing experience.
  • Experience with Automated Test Equipment (ATE).
  • Experience with regard to Measurement Systems Analysis/GRR principles, including study design/execution/troubleshooting
  • Strong critical thinking, problem solving, risk assessment, and risk management skills.
  • Must be capable of working on multiple projects in a deadline driven environment.

 

EU Medical Device,21CFR820,Quality System Regulation,design verification/validation,Automated Test Equipment ,ATE,Gage R&R
 

Recommended skills

Testing
Risk Analysis
Statistical Process Controls
Process Improvements (Business)
Measurement Systems Analysis
Design Failure Mode And Effects Analysis
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Job ID: 242350

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