Quality Engineer II - Electronics

Penumbra•Alameda, CA

1d•$95,000 - $127,000•Onsite

About The Position

The Quality Engineer II develops and implements appropriate quality system elements to ensure the high-quality level of new and existing products as well as their compliance with applicable regulations and standards. Work with problems of moderate scope where the analysis of situation or data requires a review of identifiable factors. Exercise judgment to determine appropriate action. Communicate and implement quality objectives.

Requirements

Associate’s or Bachelor's degree in Engineering, a Life Science, or a related field, with 2+ years of quality engineering or relevant experience, preferably in a medical devices or regulated industry environment, or equivalent combination of education and experience.
Familiarity with QSR, ISO and other applicable regulations and laws required
Engineering experience in a manufacturing environment recommended, medical device industry preferred
Experience with Electronic devices and or PCBAs
Excellent verbal, written, and interpersonal communication skills
Proficiency with MS Word, Excel, and PowerPoint

Responsibilities

Collaborate in the development and qualification activities for new and existing products
Collaborate in the development of testing and inspection methodology and documentation for new and existing products
Collaborate on Quality Objective teams
Design and install QC process sampling systems, procedures, and statistical techniques
Design or specify inspection and testing mechanisms and equipment
Perform failure analyses and defect investigations
Analyze production limitations and standards
Recommend revision of specifications
Interface with other engineering departments within the company, customers, and suppliers on quality related issues
Collaborate in the development of standard operating procedures
Facilitate and perform internal audits
Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.
Ensure other members of the department follow the QMS, regulations, standards, and procedures.
Perform other work-related duties as assigned

Benefits

medical
dental
vision
life
AD&D
short and long-term disability insurance
401(k) with employer match
paid parental leave
eleven paid company holidays per year
a minimum of fifteen days of accrued vacation per year, which increases with tenure
paid sick time in compliance with applicable law(s)