Quality Assurance Engineer
Hollister Incorporated
- Kaunas
- Pastovus
- Pilnas etatas
Department: QualityResponsibilities:
- Meeting all regulatory compliance requirements of the Quality System,
- Planning, coordinating, executing, documenting and performing pFMEA, validation studies, process capability studies and process improvements
- Responding to assigned customer complaints and CAPAs for investigation, root cause analysis, and solution implementation
- Partnering with operations in achieving both plant Global Quality Management objectives compatible with Hollister’s Mission and Vision
- Participate (by reviewing and evaluating impact) in disposition of non-conforming material decision-making process.
- Support test method implemetation and recommend equipment purchases
- Manage Change Control Requests as a quality resource
- Develop Quality Plans and work instructions, documenting procedures
- Conduct defect awareness training sessions
- Support internal/external audits
- 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
- 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).
- Knowledge and experience in statistical software packages preferred (ex. Minitab)
- Technical knowledge in systematic injection molding techniques and film sealing preferred
- 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: 32884