Lead Quality Assurance Engineer

Data: 2025-01-03

Vieta: Kaunas, LT, LT-54462

Įmonė: Hollister Incorporated

Padarome gyvenimą pilnavertiškesniu ir oresniu

Vieta: Kaunas 
Padalinys:  

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

 

Company offers:

  • 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:

3000-3800 €/month gross after assessing your competencies and work experience.

Apie „Hollister Incorporated“
„Hollister Incorporated“ yra nepriklausoma, darbuotojų valdoma įmonė, kurianti, gaminanti ir parduodanti sveikatos priežiūros produktus visame pasaulyje. Bendrovė investuoja į novatoriškų stomos priežiūros, šlapimo šalinimo sutrikimų ir kritinės priežiūros produktų pažangą, taip pat kuria mokomąją pagalbinę medžiagą pacientams ir sveikatos priežiūros specialistams. „Hollister“, kurios būstinė yra Libertyville mieste, Ilinojaus valstijoje, JAV, turi gamybos ir distribucijos centrus trijuose žemynuose ir vykdo pardavimus beveik 80 šalių. „Hollister“ yra „The Firm of John Dickinson Schneider, Inc.“ dukterinė įmonė ir vadovaujasi savo Misija – padėti žmonėms, naudojantiems mūsų gaminius ir paslaugas, gyventi oriau ir patogiau. Mūsų Vizija - augti ir klestėti kaip nepriklausomai, darbuotojų valdomai įmonei, kartu tampant geresniais žmonėmis. Sužinokite daugiau www.Hollister.com.

EOE Statement 
Visi tinkami kandidatai bus svarstomi dėl įdarbinimo, neatsižvelgiant į rasę, etninę kilmę, religiją, lytį, seksualinę orientaciją, lytinę tapatybę, tautinę kilmę, negalią ar apsaugoto veterano statusą.

Darbo užklausos ID: 34007