Senior Quality Assurance Engineer

Date:  Feb 2, 2024
Location(s): 

Kaunas, LT, LT-54462

Location(s): 

Kaunas, LT, LT-54462

Company:  Hollister Lietuva UAB

We Make Life More Rewarding and Dignified

Location: Kaunas 
Department: Quality 

 Responsibilities:

  • Serve as Quality Resource for new product development, current product sustainability and improvement

  • Act as Quality Resource for completion of Change Control Requests

  • Lead and perform pFMEA and qualifications for new product launches

  • Participate in disposition of non-conforming material decision-making process

  • Respond to assigned customer complaints and CAPAs for investigation, root cause analysis and implement solutions

  • Plan, coordinate, execute and document studies for Quality Plans and work instructions process capability, validation and process improvement

  • Create, execute and conclude results for protocols including final report and summaries

  • Support Operations and GQM strategic plans in leading or supporting projects

  • Work as problem-solving lead/ facilitator by using LEAN tools.

 

 

Requirements:

 

  • Number of Overall Years Necessary: 5-8

  • 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 required

  • Knowledge and application of basic statistics and experimental design

  • Experience in microbiology and sterilization (gamma/EtO) and with product design and product design related regulatory requirements processes preferred

  • Knowledge and implementation of medical device Quality System requirements (FDA and ISO)

  • Certified Quality Engineer (CQE) and knowledge of Lean and Six Sigma Black Belt principles

  • Experience in Internal and/or External auditing, Quality Auditor Certification (CQA) preferred

  • Knowledge of SAP/ERP Systems 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
2600-3500€/mon. gross

Hollister Incorporated is an independent, employee-owned company that develops,manufactures, and markets healthcare products worldwide. The company develops and manufactures products for ostomy care, continence care and critical care, and also develops educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, it 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 (JDS Inc), a 100 year old company. Hollister is guided by the shared Mission of JDS Inc, to make life more rewarding and dignified for people who use its products and services.  www.Hollister.com 

Hollister is an EO employer – M/F/Veteran/Disability


Job Req ID: 32245


Job Segment: Quality Assurance, Computer Science, ERP, SAP, Technology, Customer Service