Engineer II – Quality Assurance Engineering

Emploi Slovaquie

Titre du poste : Engineer II – Quality Assurance Engineering

Titre du poste : Engineer II – Quality Assurance Engineering

Entreprise : Convatec

Description du poste : Pioneering trusted medical solutions to improve the lives we touch: Unomedical s.r.o. is a member of Convatec which is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.comPlace of work: Priemyselný park 3, Michalovce, SlovakiaWage (gross) and other rewards: Minimum 1450€ / monthly (depending on experiences and quality of the candidate) + quarterly bonus and other benefits in compliance with social benefit program of the companyContract type: full-timeStart date: by agreementAbout the role:Engineer II – Quality Assurance Engineering 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 Engineer II – Quality Assurance EngineeringActively supports and influences technology transfer teams in the translation of product DesignRequirements into Manufacturing Requirements; including the Quality Control Plan and ensures that theseare included in the Design and Development Plans and addressed timely in Design Reviews. Assures workis complete, meets standards and requirements appropriate for the type of productSupports the introduction of new GxP equipment into production, providing guidance and enforcing highquality standards throughout the respective projectSupports the implementation of continuous improvement activities by assessing impact on the Qualitysystem and providing guidance on appropriate activities required for implementationInvestigates process and product performance issues and leads or participates in multifunctional evaluationof products in the marketEvaluates data using statistical toolsLead or support Complaint investigations through Root Cause Analysis and effective Corrective orPreventive Actions (CAPA)Lead or actively support Product Change ControlSupports manufacturing, providing guidance to ensure high quality standards are maintainedPerforms and/or supports investigations relating to Manufacturing/validation/equipment issuesProvides leadership as subject expert in Risk management and Control plan activities. Maintains riskmanagement procedures, ensuring alignment with relevant regulatory standardsProvides leadership as subject expert in validation, completes assessment of validation requirementsassociated with a change in the processMaintains validation procedures, ensuring alignment with relevant regulatory standardsParticipate in revalidation assessments for GxP processes across site in compliance with Site MasterLead/Participate Process FMEA,Update HAR, UFMEA or DFMEAPerform HHE, stopshipsAbout you:Demonstrated experience in Pharma/Medtech industry – preferredKnowledge and experience of working with a Quality Management System within Medical DevicemanufacturingDemonstrated experience in a quality engineering or a similar role in a medical device or life sciencestechnology driven companyDemonstrated application of change control processes in a complex and regulated manufacturingenvironmentExperience 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 211Project management expertise including managing multiple projects – preferredPosition is also suitable for a fresh graduateQualifications/Education: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 9001 – preferredOur ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen, too.It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it.This is stepping up to a challenge.This is work that’ll move you.Employee perks, benefits: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 rightHome 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.Company:Unomedical s.r.o. (member of the global company Convatec)
Priemyselný park 3
071 01 Michalovce, SlovakiaEmail:
| |#FLI-DB1#LI-OnsiteBeware of scams online or from individuals claiming to represent ConvaTecA formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official ConvaTec email address.If you receive a suspicious approach over social media, text message, email or phone call about recruitment at ConvaTec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at .Dajte si pozor na podvody online alebo od jednotlivcov, ktorí tvrdia, že zastupujú spoločnosť ConvaTecPred akoukoľvek ponukou práce, sa vyžaduje formálny náborový process, pre všetky naše pracovné príležitosti.To bude zahŕňať, pracovný pohovor potvrdený oficiálnou e-mailovou adresou spoločnosti ConvaTec.Ak Vás osloví podozrivý kontakt cez sociálne médiá, textovú správu, e-mail, alebo telefonát, o nábore v spoločnosti ConvaTec, nezverejňujte žiadne osobné údaje, ani neplaťte žiadne poplatky.Ak si nie ste istí, kontaktujte nás na adrese .Equal opportunitiesConvaTec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.Rovnaké príležitostiConvaTec poskytuje rovnaké pracovné príležitosti, pre všetkých súčasných zamestnancov a uchádzačov o zamestnanie. Táto politika znamená, že nikto nebude diskriminovaný z dôvodu rasy, náboženstva, vierovyznania, farby pleti, národnostného pôvodu, národnosti, občianstva, pôvodu, pohlavia, veku, rodinného stavu, fyzického alebo mentálneho postihnutia, citovej, alebo sexuálnej orientácie, rodovej identity, vojenského statusu, alebo statusu veterána, genetických predisponujúcich vlastnosti, alebo z akéhokoľvek iného dôvodu, zakázaným zákonom.Notice to Agency and Search Firm RepresentativesConvaTec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any ConvaTec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of ConvaTec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.Upozornenie pre zástupcov agentúr a vyhľadávacích spoločnostíSpoločnosť ConvaTec neprijíma nevyžiadané životopisy od agentúr a/alebo vyhľadávacích spoločností pre túto pracovnú ponuku. Životopisy predložené akémukoľvek zamestnancovi spoločnosti ConvaTec, treťou stranou, ako sú agentúry a/alebo vyhľadávacie spoločnosti, bez platnej písomnej a podpísanej zmluvy o vyhľadávaní, sa stanú výhradným vlastníctvom spoločnosti ConvaTec.Already a ConvaTec employee?If you are an active employee at ConvaTec, please do not apply here. Go to the Career Worklet on your Workday home page and View « ConvaTec Internal Career Site – Find Jobs ». Thank you!Ste už zamestnancom spoločnosti ConvaTec?Ak ste aktívnym zamestnancom spoločnosti ConvaTec, prosím, neaplikujte tadiaľto. Prejdite na stránku pracovných príležitosti, na svojej domovskej stránke Workday a zobrazte si „Interná kariérna stránka spoločnosti ConvaTec – Nájsť pracovné miesta“. Ďakujeme!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:Na osobný pohovor budú pozvaní uchádzači, ktorí spĺňajú naše požiadavky. Materiály neoslovených uchádzačov budú v súlade s nariadením GDPR a so zákonom o ochrane osobných údajov skartované.
Informácia o spracúvaní osobných údajov uchádzačov o zamestnanie sa nachádza na:

Salaire attendu :

Localisation : Michalovce, Košický kraj

Date du poste : Fri, 06 Jun 2025 00:31:13 GMT

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