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. Group revenues in 2022 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 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

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 Senior Engineer – Business Quality (Senior Quality Compliance Engineer) , and you’ll drive progress that really means something.

About the role:

As a Senior Engineer – Business Quality (Senior Quality Compliance Engineer) you will be responsible of maintaining high quality standards for the product manufacturing and compliance with all applicable regulatory requirements. The scope is focused on Quality Compliance processes and is assured via the execution of the Corporate Quality Compliance Programs.

Your key duties and responsibilities as a Senior Engineer – Business Quality (Senior Quality Compliance Engineer) :

Internal Audit Process :

• Execute the Internal Audit Process in the organization according to the site schedule

• The position provides leadership, oversight, and strategic guidance for site issues related to Quality Compliance

• Ensure that the Quality Management System is periodically evaluated and audited and appropriate CAPA is taken to meet the business and regulatory requirements

• Ensure robust investigation of Audit Observations and adequate CAPA action plans, ensure alignment in Audit Non Conformance Ratings

• Liaise with Site Leaders on assessing gaps and defining actions plans related to Internal Audit Non Conformances

• Analyse Internal Audit data for systemic trends, drive compliance and improvement in Internal Audit Metrics

• Gather and analyse data as an input to the Management Reviews to allow meaningful review

• Support Internal Audit and Corporate Audits as required

External Audit Process :

• External audit process execution, from readiness, to execution, response and tracking of commitments

• Provides leadership, oversight, and strategic guidance for companywide issues related to Quality compliance

• Liaise with Quality Leaders on assessing gaps and defining actions plans related to External Audit Non-Conformances, reviewing and approving responses to Notified Body/Health Authorities as applicable

• Gather and analyse data as an input to the Management Reviews and/or CAPA Review Board

Compliance and Education Program :

• Contribute to the development of Corporate training materials to execute the Internal Audit Program and compliance education trainings (QSR, ISO, GMPs)

• Coach/train internal auditors

• Keep abreast of all current regulatory and statutory expectations

• Support Regulation/Standard Gap Assessments and implementation as required

Inspection readiness:

• Enable successful product realization and compliance through readiness compliance activities, assessments, and other consultation

• Ensure sites are in permanent state of inspection readiness using readiness tools

• Support coordination of responses to Notified Bodies to ensure SME and Management engagement and buy-in

• Performs and lead Gemba walks as part of readiness activities

Health Authority:

• Support External Audits and responses

Other responsibilities:

• Support other projects as required by the business

About you:

• Internal Lead Auditor Certification and experience in executing audits

• Excellent written and verbal communication skills, with an open, collaborative, interactive leadership style

• Ability to build and nurture strong and positive relationships with other leaders to partner effectively

• Balanced technical understanding of products and processes combined with business and compliance acumen

Education / Qualifications:

• Minimum of B.S., or equivalent, in a scientific/technical discipline is required

• Five to Ten (5-10) years in the medical device and/or pharmaceutical industry preferred.

• We welcome candidates with experience in Manufacturing, Validation, and Quality roles within the Medical Devices sector, who possess a willingness to develop Compliance skills.

• Two to Four (2-4) years’ experience in a QA/QC role.

• Practical experience and global mastery in global quality standards and regulations governing medical products.

• Communicative level of English language

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.

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

• Convatec Day – extra day off

• 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 0.17 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 (no pandemic situation)

• 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

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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 : http://www.convatec.sk/o-nás/kariéra/ (http://www.convatec.sk/o-n%C3%A1s/kari%C3%A9ra/)

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: http://www.convatec.sk/o-nás/kariéra/ (http://www.convatec.sk/o-n%C3%A1s/kari%C3%A9ra/)