Sr Design Assurance Quality Engineer

Padarome gyvenimą pilnavertiškesniu ir oresniu

Vieta: Kaunas 
Padalinys: 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.

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: 33928