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. Group revenues in 2024 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 We are guided by our five core values, that shape the way we work, every day: Improve Care, Deliver Results, Grow Together, Own It and Do What’s Right. Place of work: Priemyselný park 3, Michalovce, Slovakia Wage (gross) and other rewards: minimum 1800€ / monthly (depending on experiences and quality of the candidate) + annual global incentive plan-bonus and other benefits in compliance with social benefit program of the company Contract type: full-time Start date: by agreement At Convatec, we’re transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. We’re aiming for nothing short of excellence. Join us on our journey to #ForeverCaring as an Advanced Operations – Senior Quality Engineer, and you’ll do the same. **About the role:** **Senior Quality Engineer - Advanced Operations** is responsible for guiding the new product development and technical teams on the adherence to applicable regulations and internal procedures whilst focusing on manufacturing quality critical attributes for a successful launch of a new product within Ostomy Care & Continence Care. You will provide leadership as a subject matter expert in, Manufacturing feasibility and capability, Risk Management, inspection & test methods, Statistical Sampling, and quality improvement activities for all NPD projects progressing through the IDEAL stage gate process, resulting in a successful transfer from R&D into full production. **Your key duties and responsibilities:** + Lead the IDEAL stage gated process for new products, ensuring timely deliverables for both internal and external manufacturing. + Act as the Manufacturing Quality expert, guiding teams through the IDEAL process to maintain high-quality standards. + Collaborate with Design Assurance to align on product risk assessment and essential design outputs (EDO). + Translate design outputs into critical-to-quality (CTQ) characteristics, ensuring effective measurement and control. + Identify and support the development of test methods to monitor CTQ performance against strict criteria. + Provide guidance on selecting production and test equipment to meet quality specifications, including supplier site visits. + Oversee gage R&R and Test Method Validation activities for reliable data. + Develop and apply effective sampling plans for validation and production stages. + Support process development with statistical techniques and Design of Experiments. + Ensure compliance with validation procedures and write, review, and approve validation documentation. + Maintain and update global Quality Control Procedures and PFMEA risk documents. + Lead Root Cause Analysis and problem-solving for new product introduction. + Manage supplier quality to prevent raw material issues. + Work with third-party manufacturers to ensure quality management system controls. + Oversee the final handover of new products to the plant quality team. + Mentor and coach lower-level team members in quality disciplines and methodologies. + Ensure compliance with EHS requirements and contribute to company targets. **Competencies:** + Manufacturing quality experience. + Strong process validation and computer systems validation lifecycle experience (preferred). + Risk management experience (PFMEA, HA, DFMEA, UFMEA). + Experience in implementing/reviewing pFMEA and QCPs. + Ability to act as a manufacturing quality SME in critical projects. + Experience in New Product Development from ideation to launch. + Coaching/mentoring experience. + Knowledge of statistical software (preferably MINITAB). + Strong interpersonal skills and cross-functional project experience. + Practical knowledge of change control implementation. + Understanding of complaint handling systems (21 CFR 820, 803, ISO 13485, ISO 9001, GMP Parts 201 and 211). **Skills & Experience:** + **Minimum 3+ years in a similar role** , preferably within the medical device industry but not essential. + Knowledge and experience in operations and manufacturing quality. + Competent in the development and change of key process documentation i.e. Standard Operating Procedures, Process instructions, material specifications etc. + Knowledge and experience in application of Statistical sampling techniques + Experience performing risk analysis & management. + Negotiation, persuasion and influencing skills to achieve objectives. + Experience of notified body audits and FDA inspections. + Experience in project/process management. + Confident presentation skills. + Operating in a team environment, working on multiple projects, and changing priorities. + Analytical mind, technical and communicative skills. + Self-development through continuous learning and knowledge sharing. **Qualifications/Education:** + Degree or equivalent in science, engineering, or related discipline. + Statistical know-how, Lean Principles and/or Six Sigma Green Belt + Proficient in Office (Excel, Word, and PowerPoint), Statistical software (MiniTab, etc.), TrackWise. **Travel Requirements:** Yes – Minimal as required for business needs (International & Domestic), travel may be 25% of the time or greater, mostly within Europe. **Working Conditions:** + Office based position at the Michalovce plant with home office possibilities. + Flexible working hours. Our 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. **Note:** **Please send your CV only in English language.** **Employee perks, benefits** + Annual global incentive plan-bonus + 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 **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-CC1 \#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/_