Sr QE/QA Manager, Medical Device Start-up, Menlo Park, CA- 135k

Menlo Park  ‐ Onsite
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Description

MAJOR DUTIES AND RESPONSIBILITIES
  • Responsible for supporting the complete life cycle of a new/modified product, from concept to design transfer, on-going engineering efforts and production support
  • Primary quality resource for dealing supply chain issues for key suppliers
  • Fundamental understanding of regulations related to medical device quality specifically ISO 13485, ISO14971, 21 CFR Part 820
  • Acts as a primary quality representative on design phase and technical reviews.
  • Assists in the creation of product and component specifications and inspection requirements.
  • Performs formal risk analysis, develop risk control measures and mitigations, and create FMECA in support of risk management.
  • Subject matter expert on biocompatibility, sterilization, and packaging validation requirements.
  • Excellent writing skills to generate protocols and test methods.
  • Performs and participates in internal, supplier, and external audits as required
  • Supports overall production through technical oversight of quality inspectors
  • Ability to drive innovative, compliant solutions to complex challenges drawing from a broad knowledge of principles, practices, and procedures.
  • Familiarity managing quality systems such as complaints, CAPA, handling non-conforming material, rework, calibration, validation, and supplier quality management.
  • Reports observations/problems clearly and concisely, recognizing and highlighting specific deviations and presents possible solutions.
  • Develops system level design strategies and may lead design, development, testing & refinement of components and sub-systems.
  • Recommends and implements changes in quality system procedures and processes.
  • Collaboration with other engineering disciplines to ensure that the device will accomplish the design goals.
  • Able to work independently with a minimum of supervision and direction.


Requirements:
  • Bachelor's degree in a technical discipline
  • 7+ years medical device experience
  • Knowledge of ISO 13485 and ISO 14971 requirements
  • Ability effectively multitask and prioritize
  • Good communication skills, hard worker and self-starter
  • Analytical and detail oriented mindset
  • Experience with Class III / PMA products highly desired
  • Experience and certification in performing audits desired


To find out more about Real please visit www.realstaffing.com
Start date
02/2014
From
Real Staffing
Published at
20.02.2014
Project ID:
667923
Contract type
Permanent
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