Lead Incoming Quality Assurance Technician
Kaunas, LT, LT-54462
Kaunas, LT, LT-54462
We Make Life More Rewarding and Dignified
Location: Kaunas
Department:
Responsibilities:
- Coordinate inspection of incoming materials (lab testing, visual checks, documentation review) using appropriate measurement tools.
- Prepare procedures, Quality Plans, and Standard Work Instructions to maintain QMS compliance with ISO and regulatory requirements.
- Oversee incoming quality testing equipment (calibration and maintenance).
- Prepare material sort/rework documentation.
- Analyze raw material data and report quality metrics.
- Ensure proper management of non-conforming material areas (e.g., Reject Cage, Hold areas).
- Support the team with incoming inspection methods, measurements, and documentation.
- Lead investigations and problem-solving for non-conforming raw materials with internal teams and suppliers.
- Participate in non-conforming material disposition decisions.
- Collaborate with Manufacturing to identify and resolve raw material quality issues.
- Represent incoming inspection during internal and external audits.
- Lead or support CAPAs, including root cause analysis and implementation of solutions.
- Contribute to Change Control processes as a Quality representative.
- Deliver training on raw material defect awareness.
Requirements:
- 5–8 years of overall professional experience.
- Minimum 1 year in the medical device or similar regulated industry.
- Experience with medical device Quality Systems (21 CFR 820 and/or ISO 13485 preferred).
- Bachelor’s degree in Engineering, Mathematics, Natural Sciences, or related field (required).
- Master’s degree in a relevant technical or business field (preferred).
- Strong mathematical, analytical, and communication (written and verbal) skills.
- Knowledge of GMP, ISO standards, and FDA regulations.
- Strong technical writing skills and attention to detail.
- Experience with ERP systems (preferred).
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Project, Access).
- English and Lithuanian language required.
Company offers:
- Learning and development-oriented culture.
- Annual bonus based on personal performance.
- A benefits package, including health insurance, to support your well-being.
- Flexible working hours.
- Fresh and healthy breakfast and lunch at our site's restaurant, available at an exclusive company price.
- Team-building, summer festivals, and special events.
- Associate well-being program – free professional consultations with psychology, law, and finance specialists.
- Free charging stations for electric cars.
- 24/7 accident insurance.
We guarantee confidentiality and will inform only selected candidates.
Salary:
2100-3300 €/mon. gross
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: 36146
Job Segment:
Quality Assurance, Technical Writer, Compliance, ERP, Law, Technology, Legal