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Senior Manager Quality Assurance (MedTech)

5 800 - 7 600
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 Manager Quality Assurance (MedTech): Leading site-wide quality assurance and quality management system activities for healthcare product manufacturing with an accent on regulatory compliance, audit readiness, and continuous improvement. Focus on managing QA teams, strengthening CAPA and risk processes, harmonizing quality practices, and coordinating with manufacturing, regulatory, R&D, and global quality stakeholders.

Location: Kaunas, Lithuania

Salary: €5,800–€7,600 gross per month

Company

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

What you will do

  • Lead site-wide quality assurance and Quality Management System activities, ensuring compliance with internal, regulatory, and external requirements.
  • Maintain audit readiness, identify and mitigate quality risks, and ensure timely CAPA completion.
  • Manage, lead, and develop a high-performing QA team while building a culture of accountability and continuous learning.
  • Drive quality process standardization, harmonization, efficiency initiatives, change management, and risk assessment.
  • Establish and track quality KPIs, communicate performance trends, and escalate risks and improvement opportunities to senior leadership.
  • Represent the site in inspections, audits, regulatory interactions, Quality Management Reviews, and global quality initiatives.

Requirements

  • Bachelor’s degree and 12–15 years of related experience.
  • Thorough knowledge of Quality Management System elements and applicable requirements, including ISO 13485, ISO 14971, FDA 820.30, MDD, and MDR.
  • Experience managing internal and external audits and representing a company in interactions with notified bodies and regulatory agencies.
  • Knowledge of continuous improvement and root-cause problem solving in a manufacturing environment.
  • Strong project management, analytical, communication, interpersonal, and cross-functional collaboration skills.
  • Experience with fiscal management and change management.

Nice to have

  • Advanced degree.

Culture & Benefits

  • Learning and development-oriented culture.
  • Annual performance-based bonus.
  • Health insurance and 24/7 accident insurance.
  • Flexible working hours.
  • Company-priced breakfast and lunch at the site restaurant.
  • Team-building activities, summer festivals, special events, and free electric-car charging stations.

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