Location: Carlsbad, California
Posted On: 6/12/2017
Job Code: QA_CA_2397
Job Description
Job Title: Principal Software Quality Engineer

Per Note from the Manager:
1. Wants candidate with Design control background, 62304, 60601, and ventilation standards
2. Must have Med Device background and risk management background.
3. This is NOT a software testing or software development associated position.

Minimum requirements:
Education / Experience: BS with 10+ years (minimum 8 years relevant medical device experience)
Minimum 6 years as software quality engineer supporting design controls
Desirable but not essential:
• MS with 8+ years
• PhD with 5+ years
Preferred Skills/Competencies:
Good verbal and written communication skills including protocol / report development and technical presentations.
Risk Management, ISO 14971, FTA, FMEA, HACCP.
Familiarity with Hardware EE Design & Development: Design Margin, Component Derating, Creep & Clearance, In Circuit Test, IPC, IEC 61000, Design of Experiments & Reliability Analysis
Previous experience working in a cross-functional team environment.
ASQ CQE, CQA, CSQE and/or CRE certification.
Familiar with statistical software tools (Minitab, Stat Graphics, Statistica),
Stability, HALT/HASS.
Familiar with IEC 60601, IEC80601-2-12 and product specific industry standards.
Familiar with DMAIC or DMADV(DFSS) methodologies
DFSS / Lean Green Belt or Black Belt
Other Skills: Computer literate and experience with PCs, networks, and applications

The Principal Software QA Engineer will participate in the execution of new product development and product sustaining activities specifically for ventilators and associated accessories. The SW QE will be responsible for administration of quality assurance programs, policies, processes, procedures and controls in compliance with internal and external requirements. The individual will act as a subject matter expert and provide guidance to the business in interpreting and executing against Client’s quality system elements including software work products to ensure compliance. This individual will ensure that all system-level project / program work products (e.g., plans, requirements, specifications, tests, test results, traceability, risk management documents, reports) meet Client’s’s quality, reliability, and compliance requirements. May provide support in resolution of product CAPA’s, complaints and/or safety issues involving software.
Category:IT  code:new
Job Requirements
Quality Assurance, Compliance, Risk Management, ISO 14971, FTA, FMEA, HACCP, Design control, 62304, 60601,ASQ CQE, CQA, CSQE and/or CRE certification, EC 60601, IEC80601-2-12, DMAIC or DMADV(DFSS)

Not Ready to Apply?
Contact Details
Kunal Shah
E-mail Address