обновлено 4 часа назад
Quality Engineer II (Medical Devices)
95 000 - 127 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Engineer II (Medical Devices): Developing and implementing quality systems, testing methods, inspection processes, and compliance controls for new and existing medical device products with an accent on quality engineering, manufacturing, and regulatory standards. Focus on failure analysis, defect investigations, statistical sampling, internal audits, and maintaining compliance with QMS, QSR, and ISO requirements.
Location: Alameda, California; on-site
Annual base salary: $95,000–$127,000
Company
is a global healthcare company that designs, develops, manufactures, and markets innovative medical products for challenging medical conditions.
What you will do
- Develop and qualify new and existing medical device products.
- Develop testing, inspection, sampling, and statistical quality methods and documentation.
- Perform failure analyses, defect investigations, and production limitation analyses.
- Design or specify inspection and testing mechanisms and equipment.
- Collaborate with engineering departments, customers, suppliers, and Quality Objective teams on quality-related issues.
- Facilitate internal audits, develop standard operating procedures, and implement quality objectives.
Requirements
- Associate’s or bachelor’s degree in engineering, life science, or a related field, plus 2+ years of quality engineering or relevant experience, or an equivalent combination of education and experience.
- Familiarity with QSR, ISO, and other applicable regulations and laws.
- Experience in a manufacturing environment; medical device experience is preferred.
- Experience with electronic devices and/or PCBAs.
- Strong verbal, written, and interpersonal communication skills.
- Proficiency with Microsoft Word, Excel, and PowerPoint.
Culture & Benefits
- Collaborative environment with continuous learning and performance recognition.
- Work takes place in office, laboratory, and cleanroom environments, with potential exposure to blood-borne pathogens.
- Medical, dental, vision, life, AD&D, short- and long-term disability insurance, and a 401(k) with employer match.
- Paid parental leave, eleven company holidays, at least fifteen days of accrued vacation, and paid sick time.
- Physical requirements include lifting or moving up to 25 pounds and moving between buildings and floors.
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