Sr Design Assurance Quality Engineer

Date:  Dec 10, 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:

  • Guide cross-functional teams in the appropriate application of design controls in compliance with global regulatory requirements for medical devices
  • Facilitate project quality activities addressing design and process verification / validation for new products and significant changes to existing products or processes
  • Facilitate design FMEA, participate in process FMEA, and conduct risk assessments in compliance with ISO 14971
  • Support Specification and Test Method Development, Clinical, Design Verification and Validation
  • Interface with Hollister plant and supplier Quality Engineering and Quality Assurance for new products and significant changes to existing products or processes
  • Utilize parametric and nonparametric statistical analysis methods to ensure products/processes are appropriately characterized and qualified prior to market release
  • Support review of Preproduction submissions from the Hollister plants and suppliers for new products and significant changes to existing products or processes
  • Strong knowledge on subject matters related to principles and practices of Quality Engineering
  • Participate in internal, supplier, and external regulatory agency audits / inspections as required

 

Requirements:

  • 5-8 years of experience in medical device industry. Background in Quality Engineering and/or New Product Development/R&D
  • Bachelor of Science degree or higher in Engineering or Physical Sciences
  • ASQ Certified Quality Engineer and/or ASQ Certified Reliability Engineer strongly preferred
  • ASQ Certified Manager of Quality / Operational Excellence or Six Sigma Black Belt certificate is a plus
  • Working Knowledge with Statistics and Statistical Tools (Statistica, Minitab, Excel)
  • Knowledge of Validation processes and FMEA creation
  • Experience with Design Controls and/or product development
  • Experience with the EU MDD/MDR directives and regulations and ISO 13485 environment at a medical device manufacturer
  • Project management training and experience
  • Experience with product development, design controls, and risk management for medical devices (ISO 14971)
  • Professional proficiency in English

 

Company offers:

  • Learning and development-oriented culture
  • Annual bonus based on personal performance
  • Additional bonus based on company performance
  • A benefits package, including health insurance, to support your well-being
  • Flexible working hours
  • Fresh and healthy breakfast and lunch at our site's restaurant, available at an exclusive company price
  • Team-building, summer festivals, and special events
  • Free charging stations for electric cars
  • 24/7 accident insurance.


We guarantee confidentiality and will inform only selected candidates.

 

Salary:

2000-3000 €/month Gross
From 2000 (before taxes) after assessing your competencies and work experience.

 

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.

EOE Statement
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job Req ID: 33928


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