Sterilization QE

Unomedical s.r.o.

Place of work
Priemyselný park 3, Michalovce
Contract type
full-time
Start date
by agreement
Wage (gross)
1 100 EUR/monthminimum 1100€ / monthly (depending on experiences and quality of the candidate) + quarterly bonus and other benefits in compliance with social benefit program of the company

Information about the position

Job description, responsibilities and duties

At ConvaTec, our vision is to develop pioneering trusted medical solutions to improve the lives we touch. We are a global medical technology business focused on serving people and care givers in the areas of advanced wound care, ostomy care, continence and critical care and infusion care. We devise, develop and manufacture innovative products and services that support people with deeply personal and challenging medical conditions, helping to improve care for them and giving them greater confidence, freedom and mobility.

We are guided by our five core values, that shape the way we work, every day: Improve Care, Deliver Results, Grow Together, Own It and Do What’s Right. We are a global Group, with over 9,900 employees and in 2020, our Group generated revenues of over $1.894 billion. To learn more about ConvaTec, please visit www.convatecgroup.com.


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 as a Sterilization QE, and you’ll drive progress that really means something.


About the role:
• Quality engineer for EO and Irradiation sterilization services and processes for Slovakia.
• Ensure the company overall performance in terms of satisfying all the prevailing quality requirements laid down in local documents regarding sterilization control.
• Day-to-day overall responsibility for sterilization control of procedures and instructions.

Your key duties and responsibilities:
• Besides providing daily management and support for environmental process and product microbiological matters and sterilization issues, the working area includes:
• Maintain up-to-date knowledge of relevant International and regional regulatory standards governing the development, production and supply of specified sterile and un-sterile medical devices
• Maintain up-to-date knowledge and experience of contemporary EO and Irradiation sterilization technologies and practices
• Devise, optimize and manage the implementation of policies and procedures for sterilization processes within Unomedical-Convatec to assure cost effective regulatory compliance
• Evaluation of physical and microbiological parameters of sterilization processes, final releasing of sterile products after sterilization
• Providing assistance to sterilization audits
• Support corporate positions with sterilization, validation/revalidation activities
• Preparation and update of instructions related to sterilization processes
• Definition and maintenance of master product for irradiation sterilization
• Review of EO and Irradiation validation documentation
• Dose audit coordination and review/approval of dose audit documentation
• Processing of NCs related to sterilization issues and environmental monitoring
• Supporting the organization in microbiology, environmental and sterilization projects
• Implementation of new or redesigned products in terms of impact on sterilization processes
• Implementation of standards requirements into local procedures
• CCRs for local processes and procedures related to sterilization, microbiology and environmental control
• Providing assistance with performing EO and Irradiation sterilization process validations
• Providing assistance with projects related to environmental monitoring and sterilization area

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
• Very 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
• 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
• Free bus transport within Michalovce city
• Social fund (various support and perks for employees)
• Flexible working hours
• Development trainings
• Career opportunities for internal employees
• Various events / team building activities for employees (no pandemic situation)
• Various employee discounts by vendors within Michalovce city

Information about the selection process

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/

Requirements for the employee

Candidates with education suit the position

University education (Bachelor's degree)
University education (Master's degree)

Language skills

English - Upper intermediate (B2)

Personality requirements and skills

About you:
• Min. 3 years experience in the Medical Device Industry – Preferred (not required)
• Proficiency in MS Office
• Experience as Auditor
• Experience with sterilization process technology within gas sterilization
• Experience with sterilization process technology within radiation sterilization
• Thorough knowledge of sterilization standards (EN ISO 11135, EN ISO 11137, EN ISO 556)
• Leadership, steadfast expertise and working in cross-functional teams
• Team player
• Organized person


Education / Qualifications:
• BSc or higher degree qualified in science / engineering
• Trained in FDA QSR’s, ISO 13485, MDSAP medical device regulations – Preferred (not required)
• English - Upper intermediate (B2)


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.

Advertiser

Brief description of the company

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. 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

To find out more please visit https://careers.convatec.com - thanks for your interest!

Number of employees

500-999 employees

Contact

Contact person: Peter Leško
E-mail: send CV
ID: 4218884  Dátum zverejnenia: 10.1.2022  Základná zložka mzdy (brutto): 1 100 EUR/month