Manager - Quality

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 2250€ / 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. 

About the role: 

The Manager – Quality ensure the all task about production are achieve with compliance with QMS system:

• Ensure the right Process FMEA, and that the Master validation plan is prepared based on QMS requirements, as well as the process validation will be done by providing statistical guidance including sampling plan.
• Assure links between control plans, process validation and sampling are maintained, as well as support Deviation handling, issue Deviations after proper risk evaluation.
• Ensure proper NC handling, NC handling within 45 days.
• Ensure Creation of sorting and reworking procedure including AQL determination and ensure employees are trained properly.
• Lead/Support Investigation of Root Causes of critical or repetitive issues, and assess/approve CAPA records within Global goals.
• Lead or support CAPA process activities, create or review correction and corrective action plans, Review effectiveness of implemented actions.
• Support complaint handling process, complaint reduction initiatives, scrap reduction and process improvements.
• Support/Perform change control process; conduct evaluation and determine impact of implemented changes.
• Lead Stop ship and HHE process – presentation and explanation.
• Supports manufacturing, providing guidance to ensure high quality standards are maintained.
• Supports the implementation of continuous improvement activities by assessing impact on the Quality ystem and providing guidance on appropriate activities required for implementation.
• Identify areas of opportunity by routine monitoring and data analysis. Ensure plant product quality documentation is updated and support implementation of Projects.
• Mentor and coach others in the practical application of procedures, understand the regulatory basis for the procedure and explain the reason behind the regulations.
• Conduct internal audits, use auditing as a proactive tool for improvements as well as assurance of compliance with existing quality requirements. Follow up on implementation of audit observation and support external audit readiness activities.

Your key duties and responsibilities as a Manager – Quality:

• Support/Lead solving of serious product quality issues.
• Review and Approval of RCI reports.
• Assessment/Approval of CAPA records.
• Support strategic QA projects, and approve final decision on serious non-conforming products and components.
• Support complaint investigation process and evaluate statistical trends and initiate corrective actions.
• Approve CCR related to manufacturing process closure if needed, and continuously monitor production activities for compliance with approved procedures/standards. Identify areas of improvement / simplification.
• Conduct internal audits, use auditing as a proactive tool for improvements as well as assurance of compliance with existing quality requirements. Lead external audit readiness of manufacturing areas Ensure activities related to production are performed.
• Lead multifunctional team, to ensure all team members are qualified and trained so that all activities above are executed and documented following defined requirements. Mentor and coach others in the practical application of procedures, understand the regulatory basis for the procedure and explain the reason behind the regulations.
• 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.

About you:

• Min. 3 years’ experience in the Medical Device Industry – Preferred.
• Fluent in English, both verbally and in writing.
• Proficiency in MS Office.
• Trained in FDA QSR’s, ISO 13485, MDSAP medical device regulations – Preferred.
• Experience as Auditor is an advantage.
• Experience with quality processes.
• Leadership, steadfast expertise and working in cross-functional teams.

Education / Qualifications: 

• BSc or higher degree qualified in science / engineering. 

Working Conditions:

• Office based position.
• Position may involve travelling on audits or other business reason.

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 0.17 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.
• 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: [email protected] 
convatec.sk | convatecgroup.com | careers.convatec.com 

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Ak si nie ste istí, kontaktujte nás na adrese [email protected].

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.

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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.

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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.

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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.