Engineer II – Quality Assurance Engineering

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. 

About the role: 

Engineer II – Quality Assurance Engineering role manages the performance of the Engineering aspects of the site’s Quality System and Quality Control processes in achieving all established user requirements and all applicable regulatory agency requirements. The role ensures compliance with Corporate Quality System procedures during Process 2 © Convatec 2023 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 an Engineer II – Quality Assurance Engineering:

• Actively supports and influences technology transfer teams in the translation of product Design Requirements into Manufacturing Requirements, including the Quality Control Plan in cooperation with cross-functional teams.
• Supports the introduction of new GxP equipment into production, providing guidance and enforcing high quality standards throughout the respective project.
• Supports the implementation of continuous improvement activities by assessing impact on the Quality system and providing guidance on appropriate activities required for implementation.
• Investigates process and product performance issues and leads or participates in multifunctional evaluation of products in the market. Evaluates data using statistical tools. Lead or support Complaint investigations through Root Cause Analysis and effective Corrective or Preventive Actions (CAPA). 
• Supports manufacturing, providing guidance to ensure high quality standards are maintained. Performs and/or supports investigations relating to Manufacturing/validation/equipment issues and maintains validation procedures, ensuring alignment with relevant regulatory standards.
• Provides leadership as subject expert in Risk management and Control plan activities. Maintains risk management procedures, ensuring alignment with relevant regulatory standards.
• Leads revalidation assessments for GxP processes across site in compliance with Site Master Validation Plan.
• 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.

About you:

• Demonstrated experience a quality engineering or a similar role. Experience in Pharma/Medtech industry would be an advantage.
• Fluency in verbal & written form of communication in ENG language
• Experience with Root cause analysis & problem-solving principles.
• Knowledge and experience with Risk Management tools & techniques.
• Knowledge and experience of working with a Quality Management System within regulated manufacturing environment is desirable.
• Regulatory and compliance knowledge and expertise in quality systems and medical devices: QSR Part 820, ISO 13485, MDD 93/42, GMP Parts 201 and 211 would be an advantage.
• Experience with Project management expertise including managing multiple or complex projects.

Education / Qualifications: 

• Degree in an engineering or scientific discipline is preferable.
• Proficient with software such as O365 (Word, Excel, PowerPoint), as well as statistical tools (e.g. Minitab), experience with ERP system such as SAP is an advantage.
• ISO 13485 Lead auditor certification is desirable.

Working Conditions:

• Office based position.
• Position may involve travelling up to 10%.

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: 

• 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 0.17 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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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.