Quality Engineer II - Electronics

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.

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

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, or equivalent combination of education and experience; Familiarity with QSR, ISO and other applicable regulations and laws required; Experience with Electronic devices and or PCBAs; Excellent verbal, written, and interpersonal communication skills; Proficiency with MS Word, Excel, and PowerPoint

Nice to have

Preferably in a medical devices or regulated industry environment; Engineering experience in a manufacturing environment; Medical device industry experience

Benefits

A collaborative teamwork environment where learning is constant, and performance is rewarded; The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases; A generous benefits package for eligible employees that includes 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, and paid sick time in compliance with applicable law(s); Competitive compensation package plus a benefits and equity program