Senior Specialist Quality Assurance
Kaunas, LT, LT-54462
Kaunas, LT, LT-54462
We Make Life More Rewarding and Dignified
Location: Kaunas
Department: Quality
Responsibilities:
- Meeting all regulatory compliance requirements of the Quality Management System
- Preparation, update QMS procedures in accordance with ISO 13485, FDA requirements and GDP
- Maintaining, archiving, and control of the documents and records
- Participation in the external and internal audits
- Administration of Quality metrics
- Corrective and Preventive action (CAPA) process coordination
- Other duties and tasks as assigned.
Requirements:
- Bachelor’s Degree in Engineering, Chemistry, Natural, Life Sciences, Social Sciences, Quality management or related study required
- 2-5 years of experience in a Quality assurance position is required
- Experience while implementing ISO 13485 and FDA requirements preferred
- Experience in medical device manufacturing regarding Quality Management System requirements preferred
- Experience working with self-directed work teams preferred
- Experience with internal/external audits
- Basic technical and GDP writing skills, experience while working with electronic document control systems required
- Problem solving skills and experience while using problem solving tools preferred
- English and Lithuanian language required.
Company offers:
- Learning and development-oriented culture
- A modern work environment
- Bonus based on annual performance
- Additional annual bonus based on company performance
- Flexible working hours
- Fresh and healthy breakfast and lunch in plants restaurant for special company price
- Free charging stations for electric cars
- Attractive motivational package (healthy snacks, company events, free coffee/tea etc.)
- Benefits package including health insurance
- Accident insurance 24/7.
We guarantee confidentiality and will inform only selected candidates.
About Hollister Incorporated
Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.
EOE Statement
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Job Req ID: 33850
Job Segment:
Quality Assurance, Document Control, Compliance, Law, Technology, Administrative, Legal