Senior Specialist Quality Assurance (Medical Devices)

TL;DR

Senior Specialist Quality Assurance (Medical Devices): Managing regulatory compliance and Quality Management Systems (QMS) for healthcare products with an accent on ISO and FDA requirements. Focus on maintaining QMS documentation, conducting audits, and administering CAPA and quality metrics.

Location: Onsite in Kaunas, Lithuania

Salary: 2300-3000 €/mon. gross

Company

Independent employee-owned company developing and manufacturing innovative healthcare products for ostomy, continence, and critical care worldwide.

What you will do

• Ensure regulatory compliance requirements of the Quality System.
• Prepare and update QMS documentation in accordance with ISO and FDA requirements.
• Maintain, archive, and control documents and records.
• Participate in internal and external audits.
• Administer Quality metrics, CAPA, Quality plans, and spreadsheet validation.

Requirements

• Bachelor’s degree in Engineering, Chemistry, Natural, Life Sciences or related field.
• 2-5 years of overall professional experience, with 1-2 years specifically in a Quality Assurance position.
• Knowledge and implementation of medical device Quality System requirements (FDA and ISO).
• Basic technical writing skills and proficiency in Microsoft Office Suite.
• English and Lithuanian language proficiency required.
• Must be based in or able to work onsite in Kaunas, Lithuania.

Nice to have

• Experience in medical device manufacturing regarding 21 CFR 820 and/or ISO 13485.
• Certification from the Certified Quality Auditor Certification Program.
• Knowledge of Lean and Six Sigma Black Belt principles.
• Experience working with SAP/ERP Systems.

Culture & Benefits

• Learning and development-oriented culture with an annual performance-based bonus.
• Comprehensive benefits package including health insurance and 24/7 accident insurance.
• Flexible working hours and on-site restaurant with breakfast and lunch at exclusive company prices.
• Associate well-being program providing free professional consultations with psychology, law, and finance specialists.
• Team-building activities, summer festivals, and free charging stations for electric cars.