7 часов назад
Quality Engineer I (Medical Devices)
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 I (Medical Devices) (Manufacturing Quality): Ensuring the quality of medical products from development through manufacturing with an accent on process validation, statistical process control, and compliance with GMP, GDP, ANSI, and ISO standards. Focus on investigating root causes, driving corrective and preventive actions, supporting audits, and improving manufacturing capability through Gage R&R, DOE, and reliability analysis.
Location: Beverly, Massachusetts, United States
Company
develops and manufactures medical and healthcare products.
What you will do
- Plan incoming, in-process, and final inspections, including flow charts, FMEAs, and control plans.
- Support products through inception, launch, maintenance, and transition from development to manufacturing.
- Support process validation, process capability improvement, customer issues, and quality system implementation.
- Prepare and review IQ/OQ/PQ protocols and reports, and establish sampling and statistical process control methods.
- Investigate root causes and determine corrective and preventive actions for NCMRs and CAPAs.
- Support audits, nonconforming product/MRB processes, technical documentation, employee training, and lean initiatives.
Requirements
- Bachelor’s degree in engineering or a related field.
- At least 3 years of experience as a Quality Engineer.
- At least 3 years of experience in a medical or healthcare product manufacturing environment.
- Knowledge of injection molding processes.
- Experience with quality standards and regulations including GMPs, GDPs, ANSI, and ISO.
- Experience with statistical quality methods such as Gage R&R, DOE, reliability strategy, and analytical problem solving.
Nice to have
- Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certification.
- Lean or Six Sigma certification.
- Project management experience.
- Experience with ERP systems such as SAP.
Culture & Benefits
- Work with a focus on accountability, innovation, integrity, quality, teamwork, safety, and continuous improvement.
- Participate in internal and external quality audits and support day-to-day quality department operations.
- Employment is offered as a full-time position.
- Freudenberg is committed to equal opportunity, diversity, and inclusion.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →