Principal Design Quality Engineer (CQE or CBA certification)

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Irvine, CA

Industry: Medical Devices & Diagnostics

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Not Specified years

Posted 376 days ago

  by    Indradeep Roy

Job Title: Principal Design Quality Engineer (CQE or CBA certification)

 

Location: Irvine, CA

 

Duration: 12+ Months Contract

Educational Qualifications: Bachelor’s Degree in Engineering or Science (Life Sciences, Physics, ME, EE, IndustrialTechnology, etc.) 

Overview:

 

  • Actively represent Design Quality Engineering function on Released Product Engineering (RPE) and Operations Sustaining project teams ensuring product design changes meet quality system requirements.
  • Develops master test plans that encompass design verification, design validation and process validation activities.
  • Leads product risk analysis in conformance withISO10497:2012. Leads strategy in in developing design bench and simulated testing. Collaborates with Clinical and Medical Safety in Clinical Risk Benefit and Clinical Evaluation analyses and reporting.
  • Leads biocompatibility assessment in conformance withISO10993-1 and FDA Guidance G87. Support product sterilization validation/yearly re-validation for dry heat and EO sterilizations.
  • Subject Matter Expertise in the application of acceptable statistical techniques and tools in product design and process testing and quality data analysis.
  • Mentor RPE Engineering staff and other personnel and ensures that design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, and design review.
  • Promotes continuous improvement in design control activities and use of quality tools with design team.
  • Specifies quality characteristics and inspection plans for components, subassemblies, and finished devices.
  • Represent as appropriate in FDA, notified body, internal, and otheraudits.

 

Day to Day responsibilities: 

  • Lead or participate in design reviews to evaluate designs and to help identify alternative design solutionist
  • Represent company as appropriate in FDA, notified body, internal, and otheraudits
  • Should have experiencewith vascular devices, embolic coils, stents, catheters, ballons, aspiration devices, coatings and /or guide wires.
  • Need to be have CQE certification (Certified Quality engineer) or CBA Certification (Certified Biomedical Auditor) 

 

Primary Skills:

  • Subject Matter Expertise in the application of acceptable statistical techniques and tools in product design and process testing and quality data analysis.
  • Lead or participate in design reviews to evaluate designs and to help identify alternative design solutionst.
  • Evaluates and dispositions nonconforming materials and products used in pilot and clinical builds, to arrive at the most economical disposition, while meeting all quality system requirements.
  • Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.

 

Secondary Skills:

  • Self-motivated and committed to a team approach
  • Strong interpersonal, organizational and project management skills
  • Strong oral, presentation and technical writing skills
  • Demonstrated skills in decision making – preferably across a broad spectrum of Quality Engineeringresponsibilities

 

$90K - $110K