Pioneering trusted medical solutions to improve the lives we touch: Convatec 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 Our search for better is changing the lives of our customers. It’s changing the careers of our people too – creating new challenges and opportunities all the time. We’re a business that never stands still. Join us on our journey to #ForeverCaring 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 **The role:** + To ensure proper CAPA and Nonconformity handling + Lead investigation teams either in case of corrective CAPA initiation or in case of preventive CAPA initiation to prevent the potential nonconformity occurrence + Determine and develop methodologies to achieve specific goals and business objectives (eg KPIs) **Key Responsibilities:** + Help to lead and coordinate activity of Investigation and root cause analysis to determine likely cause(s) of Non-Conformance + Develop and document plans to address correction (if applicable) and Corrective Action/Preventive Action activities + Prepare plan for effectiveness check activity + Review and approve activity related to: CAPA opening, NC opening, Action plans, Investigation and Root Cause analysis, Investigation and Root Cause analysis + Lead owners so that the investigation and action plan would be prepared correctly + Decide what corrective or preventive action has to be taken + Decide verification activity and effectiveness metrics + Communicate CAPA status, trending, criticality to the management team + Conduct analysis and make evaluation of trends + Lead CAPA meetings + To assist in making decision what action is necessary to do in case of nonconformity is observed + Decide of the need for opening CAPA action + Conduct analysis and trending in NC + Come up with suggestions for improvements + Monitor trends and initiate CAPA in case it is necessary. + To ensure compliance with the legislative and internal requirements of the EHS and to participate in the fulfillment of the company's targets in the EHS area **Authority (if applicable):** + Make decision to open and close Corrective and/or Preventive action + Decide to return process of corrective or preventive action back in case more work is required + Delegate investigation and preparation of CAPA plan to CAPA Owners + Lead owners for fulfilment of all CAPA requirements + Decide or verify the decision about product final disposition in case of nonconformity + Coordinate overall activities within non-conformity handling + Open NC resulted from internal audit or external audit readiness process **Skills & Experience:** + Knowledge and experience, of at least 2 years, of change control principles and associated processes + Knowledge of complaint handling, CAPA and associated processes. + Ability to handle inspections by regulatory bodies (e.g. FDA, ISO) + Ability to use statistical techniques to identify robust processes and improve existing processes **Qualifications/Education:** + Master degree at technical University + At least 2 years of minimum experience in a leadership role, preferably in the Medical Device, Healthcare industry or Food industry. + Knowledge of MDSAP, ISO 13485, MDR – preferred + Computer skills – Excel, Word, Outlook, Minitab, Quality Companion, Proficy Shop Floor, Power Point + Flexibility, creativity, communicativeness, team work, leadership Preferred training requirements: + Introduction training for administrative employees + Quality System documents and procedures relevant to all employees (local and Convatec corporate e.g. Code of Ethics and Business Conduct, Quality Policy, Complaints, relevant GxP documents), including regular re-training when required + Quality System documents and procedures relevant to job performance **Travel Requirements** The position may involve travel up to 10% of the time. Such travel may involve overnight departures. Our transformation will change your career. For good. You’ll be pushed to think bigger and aim for excellence. Your ideas will be heard, and you’ll be supported to bring them to life. There’ll be challenges. But, stretch yourself and embrace the opportunities, and you could make your biggest impact yet. This is stepping outside of your comfort zone. This is work that’ll **move** you. \#LI-AN1 \#LI-Hybrid **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/_