Quality Assurance Engineer

We Make Life More Rewarding and Dignified 

Location: Kaunas 
Department: Quality 

Responsibilities:

• 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

Requirements:

• 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

We offer:

• 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.

Salary

2300-3000 €/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. 
 

 Hollister is an EO employer – M/F/Veteran/Disability
Job Req ID: 32884