Demo

Quality Assurance Engineering Manager, Sustaining HW/SW

SciPro
Santa Clara, CA Full Time
POSTED ON 1/13/2025
AVAILABLE BEFORE 4/2/2025

Daily Responsibilities :

  • Lead and mentor Quality Engineers and Technicians.
  • Oversee Quality Transfer and Design Control to manufacturing making sure process is scalable
  • Monitor field issues of product and resolve with through collaboration with suppliers
  • Ensure compliance with regulations and industry standards.
  • Oversee daily quality activities and maintain budget.
  • Support manufacturing and operations, both internally and with external vendors.
  • Drive process improvements and participate in supplier quality activities.
  • Manage design control, risk management, and compliance for sustaining projects.
  • Conduct hardware and software verification and validation.
  • Audit Design History Files (DHFs) for compliance.
  • Investigate and document results for returned devices and complaints.
  • Maintain the Servicing Program and support distribution quality activities.
  • Analyze quality metrics and initiate Document Change Orders (DCOs).
  • Participate in audits and support regulatory submissions.

Qualifications :

  • Education : Bachelor’s in Electrical / Software Engineering (Master’s preferred).
  • Experience : 10 years in Hardware and Embedded Software Design, with 8 years in the Medical Device industry.
  • Technical Skills :
  • Analog and Digital Circuit Design, PCB Layout, and prototype development.
  • Embedded systems, version control, issue tracking, and control electronics for medical devices.
  • Management : 2 years managing others or equivalent experience.
  • Regulations : Knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 60601, 21 CFR Part 820, MDD 93 / 42 / EEC, EU MDR, and MDSAP.
  • Statistical Analysis : Proficient with Minitab and statistical techniques.
  • Preferred Experience : Class III medical devices and electromechanical products, complaint investigations.
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