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.com **Place of work:**  Priemyselný park 3, Michalovce, Slovakia **Wage (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 company **Contract type:**  full-time **Start date:**  by agreement Every day, our products improve the lives of millions of people around the world. We’re hugely proud of this, which is why we’re transforming our business to reach millions more. Join us on our journey to #ForeverCaring as a **Product Quality Engineer** , and you’ll drive progress that really means something. **About the role:** Effectively uses Scientific / Engineering knowledge and training combined with Quality Systems / Regulatory, Clinical and GXP Requirements knowledge to support Manufacturing of Medical Devices and the development of existing Products within Design Control process. 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** **Product Quality Engineer** **:** + Responsible for ensuring that Design Control requirements meet regulatory and applicable procedural requirements + Responsible for reviewing and approving design control document outputs + Works closely with R&D and Manufacturing QE’s, regulatory affairs, as well as post-market activities, & colleagues + Uses technical and GXP knowledge to influence and assure Quality and Compliance in Design and develops plans for Post Launch / lifecycle management activities + Provides leadership as subject expert in Risk Management activities and assists Design Control and actively supports and influences R&D teams in the translation of User Needs to Design + Responsible for Post Launch Reviews as appropriate + Investigates product / process performance issues and leads or participates in multifunctional evaluation of products in the market + Evaluates data using statistical tools + Leads or support Complaint investigations through Root Cause Analysis and effective Corrective or Preventive Actions (CAPA) + Leads or actively supports Product Change Control + Collates and shares information / data through reports and follows up on identified improvement opportunities + Actively participates and / or drives site / Company wide Quality System improvements as required + Responsible for FMEA (PFMEA, DFMEA, UFMEA) & Hazard analysis – autor, reviewer, approver + HHE – responsible, participates **About you:** + Experience gained within a Regulated Industry, preferable Medical Devices + Demonstrated knowledge of Regulatory and GXP Compliance requirements such as QSR Part 820, MDD 93/42, GMP Parts 210 and 211, ISO 9001 / ISO 13485. Good knowledge of Design Controls + Demonstrated knowledge and experience of Risk Management and the application and use of Risk Management Tools such as FMEA, Process Mapping, Hazard Analysis. ISO 14971 + Experience with Quality tools such as Quality Control Plans, Test Method validation and transfer, Statistics, Experimental Designs, Root Cause Analysis, Process validation, Process Optimization + Logical Thinking Skills and Experience: demonstrated ability to analyze and interpret complex problems / data gathered from a variety of sources and utilize + Demonstrated ability to effectively work and communicate in a cross-function, multinational environment building co-operative working relationships. Demonstrated ability to work effectively with multi-cultural and diverse suppliers and contract manufacturers + Good interpersonal skills and ability to influence people without direct authority + Proactive and flexible in adapting to changing environment and able to manage and prioritize work and competing objectives + Statistical knowledge, experience is desirable + Six Sigma knowledge, experience and certification is desirable + Experience of plastics, extrusion, injection moulding, assembly, bonding **Education / Qualifications:** + Degree (or equivalent) in Science or Engineering + Membership of a professional institution is desirable + Degree or proven experience in science / engineering + Must be proficient with PC programs, i.e. Excel, Word, and PowerPoint. Statistical tools (e.g. Minitab) and MS Project and SAP knowledge desirable Our products make a big difference every day. So will your contribution. The work you do will mean more, because it’ll make things better for your team, our business or our customers’ lives. It’ll inspire you to deliver to your very best. And we’ll be right behind you when you do. This is a challenge more worthwhile. 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 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 0.44Eur 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, Slovakia Email: job-slovakia@convatec.com convatec.sk | convatecgroup.com | careers.convatec.com \#LI-AP2 \#LI-Onsite **Beware of scams online or from individuals claiming to represent ConvaTec** A 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 careers@convatec.com . **Dajte si pozor na podvody online alebo od jednotlivcov, ktorí tvrdia, že zastupujú spoločnosť ConvaTec** Pred 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 careers@convatec.com . **Equal opportunities** ConvaTec 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 príležitosti** ConvaTec 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 Representatives** ConvaTec 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 spoločností** Spoločnosť 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_ _:_ _https://www.convatec.com/sk-sk/o-nas/kariera/_ _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:_ _https://www.convatec.com/sk-sk/o-nas/kariera/_