SENIOR QUALITY ASSURANCE ENGINEER
Kaunas
11 days ago
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DARBO RINKOS LYDERIS 2025
Tarp TOP 30 Lietuvoje
LEAD DESIGN ASSURANCE QUALITY ENGINEER
3100-4500 €/mon.
gross
CVbankas.lt calculator data.
Full-time
Kaunas
- UAB „Hollister Lietuva“
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.
- Ownership of Usability Engineering Files for our devices.
- 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 (ANOVA, DOE, hypothesis testing, power analysis, process capability analysis, quality control charts, regression analysis, survival analysis, measurement system analysis, acceptance sampling ANSI/ASQ Z1.4 & Z1.9) to ensure products/processes are appropriately characterized and qualified prior to market release.
- Support review of Preproduction and First Article submissions from the Hollister plants and suppliers for new products and significant changes to existing products or processes.
- Mentor and train others on subject matters related to principles and practices of Quality Engineering.
Requirements:
- Bachelor's Degree with 8-12 years of related experience.
- Background in Quality Engineering and/or New Product Development/R&D.
- Further education may reduce number of years necessary.
- ASQ Certified Quality Engineer and/or ASQ Certified Reliability Engineer preferred.
- Working Knowledge with Statistics and Statistical Tools (Statistica, Minitab, Excel)
- Knowledge of Validation and FMEA.
- 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, human factors engineering and risk management for medical devices (ISO 14971).
- Desirable: Advanced statistics training and experience with plastic injection molding and automated assembly processes.
Company offers:
- Learning and development-oriented culture.
- Annual bonus based on personal performance.
- A benefits package, including health insurance, to support your well-being.
- Flexible working hours and hybrid working model.
- 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
3100-4500
€/mon.
gross
Work place
DARBO RINKOS LYDERIS 2025
Tarp TOP 30 Lietuvoje
UAB „Hollister Lietuva“
„Hollister Incorporated“ kuria, gamina ir platina sveikatos priežiūros produktus ir paslaugas visame pasaulyje. Įmonė turi gamybos ir platinimo padalinius 3-uose žemynuose, biurus – daugiau nei 25-iose šalyse. „Hollister Lietuva“ dirba daugiau nei 900 darbuotojų. Įmonė trejus metus iš eilės tapo TOP darbdaviu Lietuvoje ir buvo paskelbta Palankiausią emocinę aplinką kuriančia įmone 2021.
UAB „Hollister Lietuva“ information
4337 €
Avg. salary gross
(2X higher than LT average)
865
Number of employees
>100 mln. €
Revenue 2025 y.
Distribution of employees by salary (before taxes):
25% earn up to
3367 €
25% earn
3367-3933 €
25% earn
3933-4758 €
25% earn more than
4758 €