Quality Engineer

Údaje o pracovnej pozícii

Id VPM

2560756

Zdroj

úrad PSVR

Názov pracovnej pozície

Quality Engineer

Profesia (SK ISCO-08)

-=KONTAKT=-Špecialista riadenia systému kvality

Pracovná oblasť

Hospodárska správa, prevádzka, požiarna ochrana a BOZP

Počet voľných miest

1

Náplň práce

About the role: Quality Engineer role manages the performance of the Engineering aspects of the site's Quality System and Quality Control processes in achieving all established user requirements and all applicable regulatory agency requirements. The role ensures compliance with Corporate Quality System procedures during Process Development, Design Transfer, Process Validation, Launch and Engineering Change activities. Collaborates with internal suppliers and customers to establish product quality requirements. Your key duties and responsibilities as a Quality Engineer: - Actively supports and influences technology transfer teams in the translation of product Design - Requirements into Manufacturing Requirements; including the Quality Control Plan and ensures that these are included in the Design and Development Plans and addressed timely in Design Reviews - Assures work is complete, meets standards and requirements appropriate for the type of product - Supports the introduction of new GxP equipment into production, providing guidance and enforcing high quality standards throughout the respective project - Supports the implementation of continuous improvement activities by assessing impact on the Quality system and providing guidance on appropriate activities required for implementation - Investigates process and product performance issues and leads or participates in multifunctional evaluation of products in the market - Evaluates data using statistical tools - Lead or support Complaint investigations through Root Cause Analysis and effective Corrective or Preventive Actions (CAPA) - Lead or actively support Product Change Control Supports manufacturing, providing guidance to ensure high quality standards are maintained - Performs and/or supports investigations relating to Manufacturing/validation/equipment issues - Provides leadership as subject expert in Risk management and Control plan activities. -Maintains risk management procedures, ensuring alignment with relevant regulatory standards - Provides leadership as subject expert in validation, completes assessment of validation requirements associated with a change in the process - Maintains validation procedures, ensuring alignment with relevant regulatory standards - Participate in revalidation assessments for GxP processes across site in compliance with Site Master - Lead/Participate Process FMEA, - Update HAR, UFMEA or DFMEA - Perform HHE, stopships

Miesto výkonu práce, Ďalšie miesto výkonu práce

Priemyselný park 3,07101 Michalovce - Michalovce
Slovensko

Ďalšie miesta výkonu práce

Pracovné podmienky

Pracovný a mimopracovný pomer

Pracovný pomer na určitú dobu

Počet mesiacov

12

Zmennosť

jednozmenná

Nočná práca

Nie

Sezónna práca

Nie

Pracovné miesto vhodné pre

Absolventa

Základná zložka mzdy v eurách (v hrubom)

1 450€mesačne

Druh voľnej pracovnej pozície

Voľné pracovné miesto v podnikateľskej sfére

Ponúkané výhody

minimum 1450€ / monthly (depending on experiences and quality of the candidate) + quarterly bonus and other benefits in compliance with social benefit program of the company. Quarterly bonus after the trial period - max. 10% from the monthly salary of the employee (based on the results of the production plant). Large corporation with representation and manufacturing plants in the world. Stable employer for Michalovce city and its surroundings. Corporate culture - Underpinning everything we do are our values: - Improve care - Deliver results - Grow together - Own it - Do what´s right Home office possibilities. Flexible working hours. Introduction program according to company standards. Development trainings. Career opportunities for internal employees. Referral bonus system. Recognition program. Meals in the amount of 0.44 Eur per one meal unit / day. Supplementary pension plan after the trial period with the employer's contribution. Social fund (various support and perks for employees). Free bus transport within Michalovce city. Various events / team building activities for employees. Various employee discounts by vendors within Michalovce city.

Požiadavky na zamestnanca

Požadovaný stupeň vzdelania

Vysokoškolské vzdelanie prvého stupňa

Vysokoškolské vzdelanie druhého stupňa

Prax

bez požiadavky na odbornú prax

Znalosť slovenského jazyka je nevyhnutná

Áno

Cudzí jazyk

anglickýstredná - pokročilá B1 a B2

Ďalšie požiadavky

About you: Demonstrated experience in Pharma/Medtech industry - preferred Knowledge and experience of working with a Quality Management System within Medical Device manufacturing Demonstrated experience in a quality engineering or a similar role in a medical device or life sciences technology driven company Demonstrated application of change control processes in a complex and regulated manufacturing environment Experience with all phases of the product development lifecycle including concept, design, implementation, verification, and validation activities necessary for product commercialization. Regulatory and compliance knowledge and expertise in quality systems and medical devices: QSR Part 820, ISO 13485, MDD 93/42, GMP Parts 201 and 211 Project management expertise including managing multiple projects - preferred Position is also suitable for a fresh graduate Education / Qualifications: University degree (engineering or scientific discipline is preferred) Proficient with software such as Word, Excel, PowerPoint, and Project, as well as statistical tools (e.g. Minitab) Knowledge of ISO 13485, ISO -=KONTAKT=-preferred

Údaje o zamestnávateľovi

Názov spoločnosti

Unomedical s.r.o.

Právna forma

Spol. s r. o.

Sídlo

Priemyselný park 3

07101 Michalovce - Michalovce

Slovensko

IČO

36597384

Počet zamestnancov

500-999

Internetová adresa

www.convatec.com/sk-sk

Charakteristika zamestnávateľa

Sme priekopníkom v zavádzaní dôveryhodných medicínskych riešení na zlepšenie životov, ktorých sa dotýkame: Unomedical s.r.o. je súčasťou spoločnosti Convatec, ktorá je globálnou firmou v oblasti medicínskych produktov a technológií. Zameriava sa na riešenia pre zvládanie chronických stavov a má vedúce postavenie v pokročilej starostlivosti hojenia rán, stómie, inkontinencie a infúznej terapie. S viac ako 10 000 kolegami celosvetovo poskytujeme naše produkty a služby v približne 90 krajinách, a to všetko spojené s prísľubom Forever caring (večnej starostlivosti). Naše riešenia prinášajú celý rad výhod, od prevencie infekcií a ochrany ohrozenej kože, až po zlepšené výsledky pre pacientov a znížené náklady na starostlivosť. Tržby spoločnosti Convatec v roku 2024 presiahli 2 miliardy dolárov. Spoločnosť je zaradená do indexu FTSE 100 (LSE:CTEC). Ak sa chcete dozvedieť viac, navštívte prosím https://www.convatecgroup.com Ďalšie informácie nájdete na https://careers.convatec.com - ďakujeme za váš záujem!

Činnosť zamestnávateľa (SK NACE Rev. 2)

Výroba lekárskych a dentálnych nástrojov a potrieb

Zabezpečenie obsadenia pracovnej pozície

Sprostredkovanie kandidátov

Vlastnou formou

Forma sprostredkovania

skupinovou formou - výberové konanie za účasti zamestnávateľa

Informácie pre záujemcu ohľadom výberového konania

Only candidates who meet our requirements will be invited for the interview. Data of not selected candidates will be deleted in compliance with GDPR and data protection law. Information about personal data processing of job seekers is located on link: https://www.convatec.com/sk-sk/o-nas/kariera/

Dátum ukončenia ponuky

09.04.2026

Kontaktná osoba

Kontaktná osoba

Mgr. Dominika Ivanová

-=KONTAKT=-