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13 дней назад

Senior Quality Assurance Engineer (Medical Devices)

2 400 - 3 700
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US/Lithuania
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Senior Quality Assurance Engineer (Medical Devices): Planning and documenting validation studies, risk analyses, audits, complaints, CAPAs, and process improvements with an accent on regulatory compliance, FMEA, root cause analysis, and process capability. Focus on coordinating quality investigations, implementing solutions, and partnering with operations to achieve plant quality objectives.

Location: Kaunas, Lithuania

Salary: €2,400–€3,700 gross per month, starting from €2,400 based on competencies and experience.

Company

hirify.global is an independent, employee-owned healthcare company developing, manufacturing, and marketing products for ostomy care, continence care, and critical care worldwide.

What you will do

  • Ensure compliance with all regulatory requirements of the Quality System.
  • Support internal and external audits.
  • Plan, coordinate, execute, and document validation studies, FMEA-based risk analyses, process capability studies, and process improvements.
  • Investigate customer complaints and CAPAs, perform root cause analysis, and implement solutions.
  • Partner with operations to achieve plant-wide Global Quality Management objectives.

Requirements

  • 2–5 years of experience in quality engineering within the medical device, pharmaceutical, biotechnology, food, or related industries.
  • Experience performing validation studies.
  • Degree in engineering, mathematics, natural sciences, computer science, or a similar field.
  • Very good English language skills.
  • Technical knowledge of systematic injection molding techniques and film sealing is preferred.
  • Experience working with self-directed teams is preferred.

Culture & Benefits

  • Learning and development-oriented culture.
  • Annual bonus based on personal performance.
  • Health insurance and a broader benefits package.
  • Flexible working hours.
  • Subsidized fresh breakfast and lunch at the site restaurant.
  • Team-building activities, summer festivals, special events, free electric vehicle charging, and 24/7 accident insurance.

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