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:
Quality Engineer 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 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 a Quality Engineer:
Actively supports and influences technology transfer teams in the translation of product Design
Requirements into Manufacturing Requirements; including the Quality Control Plan and ensures that these
are included in the Design and Development Plans and addressed timely in Design Reviews. Assures work
is complete, meets standards and requirements appropriate for the type of product
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)
Lead or actively support Product Change Control
Supports manufacturing, providing guidance to ensure high quality standards are maintained
Performs and/or supports investigations relating to Manufacturing/validation/equipment issues
Provides leadership as subject expert in Risk management and Control plan activities. Maintains risk
management procedures, ensuring alignment with relevant regulatory standards
Provides leadership as subject expert in validation, completes assessment of validation requirements
associated with a change in the process
Maintains validation procedures, ensuring alignment with relevant regulatory standards
Participate in revalidation assessments for GxP processes across site in compliance with Site Master
Lead/Participate Process FMEA,
Update HAR, UFMEA or DFMEA
Perform HHE, stopships
About you:
Demonstrated experience in Pharma/Medtech industry - preferred
Knowledge and experience of working with a Quality Management System within Medical Device
manufacturing
Demonstrated experience in a quality engineering or a similar role in a medical device or life sciences
technology driven company
Demonstrated application of change control processes in a complex and regulated manufacturing
environment
Experience with all phases of the product development lifecycle including concept, design, implementation,
verification, and validation activities necessary for product commercialization.
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
Project management expertise including managing multiple projects – preferred
Position is also suitable for a fresh graduate
Qualifications/Education:
University degree (engineering or scientific discipline is preferred)
Proficient with software such as Word, Excel, PowerPoint, and Project, as well as statistical tools (e.g.
Minitab)
Knowledge of ISO 13485, ISO 9001 - preferred
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.
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 0,44 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
#FLI-DB1
#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/