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Change Control Specialist
Unomedical s.r.o.
Place of work
Priemyselný park 3, District Michalovce
Priemyselný park 3, District Michalovce
Contract type
full-time
full-time
Start date
by agreement
by agreement
Information about the position
Job description, responsibilities and duties
• Applies Change Control and Documentation Control per 21 CFR Part 820, ISO 9001, and ISO 13485:2003.
• Ensure appropriate Change control mechanisms are developed and deployed effectively.
• Provide guidance and support for Change Control process.
• Critical review of documentation supporting change requests.
• Work on own initiative with minimal supervision while fostering and promoting a continuous improvement attitude and culture
• Supporting to manufacturing of Medical Devices and the continuous improvement activities for the Change control processes.
• Supporting of a direct superior in handling of managerial tasks to ensure compliance with QMS and regulations.
• Ensure appropriate Change control mechanisms are developed and deployed effectively.
• Provide guidance and support for Change Control process.
• Critical review of documentation supporting change requests.
• Work on own initiative with minimal supervision while fostering and promoting a continuous improvement attitude and culture
• Supporting to manufacturing of Medical Devices and the continuous improvement activities for the Change control processes.
• Supporting of a direct superior in handling of managerial tasks to ensure compliance with QMS and regulations.
Information about the selection process
Only the candidates who meet our requirements will be invited to the interview.
Requirements for the employee
Candidates with education suit the position
University education (Master's degree)
Educational Specialization
Technical field
Language skills
English - Upper intermediate (B2)
Other knowledge
Microsoft Outlook - Advanced
Personality requirements and skills
- Computer skills: MS Office, Word, Excel, Adobe Acrobat
- Knowledge of ISO 9000, ISO 13485, FDA regulations and regulatory principles with respect to Document Management, Knowledge of continuous improvement/ quality assurance methods and techniques
- Good communication level
- Managerial, leadership skills,
- Work independently
- Flexibility
- Willingness to further education
- Willingness to travel
- Orientation on detail and systematic
- Resistance to stress
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!
To find out more please visit https://careers.convatec.com - thanks for your interest!
Number of employees
500-999 employees
Contact
ID: 2244466
Dátum zverejnenia: 8.9.2015
2015-09-08
lokalita: District Michalovce Pozícia: Regulatory Affairs Specialist Spoločnosť: Unomedical s.r.o.