Quality Assurance Engineer OST
Hollister Incorporated
- Kaunas
- Pastovus
- Pilnas etatas
Department: QualityResponsibilities:
- Develop test methods and recommend equipment purchases
- Manage Change Control Requests as a quality resource
- Lead risk management processes for new product manufacturing, ensuring smooth qualification
- Participate in material disposition decisions, evaluating impact
- Investigate and resolve customer complaints and CAPAs, implementing solutions
- Conduct process studies, validations, and Gage R&R assessments
- Develop Quality Plans and work instructions, documenting procedures
- Support strategic projects aligned with Operations and GQM plans
- Conduct defect awareness training sessions
- Participate in internal/external audits
- Manage or support equipment calibration processes
- Update product drawings as needed.
- Minimum of 2 years of experience in Quality Engineering or equivalent industry disciplines
- Experience in medical device manufacturing regarding Quality System requirements per 21 CFR 820 and/or ISO 13485 preferred
- Degree in Engineering, Math, Natural Sciences, Computer Science (IT), or related study
- Knowledge and application of basic statistics and experimental design
- Good Communication skills, both written and oral
- Ability to train/facilitate
- Technical knowledge in systematic injection molding techniques and film sealing preferred
- Knowledge and implementation of medical device Quality System requirements (FDA and ISO) and Good Manufacturing Practice preferred
- Certified Quality Engineer and knowledge of Lean and Six Sigma Black Belt principles preferred
- Proficient computer skills, including Microsoft Office Suite (Word, PowerPoint, Project, Access, and Excel).
- 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.
Job Req ID: 32631