14 дней назад
Quality Engineer III - Catheters (Medical Devices)
98 000 - 137 000$
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Engineer III - Catheters (Medical Devices): Developing and implementing quality-system elements, testing methodologies, inspection processes, and regulatory-compliance activities for catheter products with an accent on medical-device quality systems, failure analysis, and statistical process control. Focus on leading product qualification, investigating defects, conducting internal audits, and ensuring compliance with QSR and ISO standards.
Location: Roseville, California, United States; on-site
Annual base salary: $98,000–$137,000
Company
develops medical devices and maintains quality systems for regulated healthcare products.
What you will do
- Develop and qualify new and existing catheter products, including testing and inspection methodologies.
- Design quality-control sampling systems, procedures, statistical techniques, and inspection mechanisms.
- Perform failure analyses, defect investigations, and production-standard analyses.
- Collaborate with engineering departments, customers, and suppliers to resolve quality issues.
- Develop standard operating procedures, facilitate internal audits, and support Quality Objective teams.
- Provide guidance to junior Quality Engineers and interns while supporting compliance with the Quality Management System.
Requirements
- Associate’s or bachelor’s degree in Engineering, Life Sciences, or a related field.
- At least three years of quality engineering or related experience, preferably in a medical-device environment.
- Familiarity with Quality System Regulations, ISO standards, and applicable regulations and laws.
- Strong verbal, written, and interpersonal communication skills.
- Proficiency with Microsoft Word, Excel, and PowerPoint.
- Ability to work on-site in Roseville, California, in office, laboratory, and cleanroom environments.
Nice to have
- Demonstrated or developing leadership skills.
- Experience in the medical-device industry.
Culture & Benefits
- Competitive compensation package with benefits and an equity program when applicable.
- Work across office, laboratory, and cleanroom environments.
- Business travel may range from 0% to 10%.
- Work includes collaboration with employees across organizational levels, engineering departments, customers, and suppliers.
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