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Change Control Coordinator
Unomedical s.r.o.
Place of work
Priemyselný park 3, Michalovce
Priemyselný park 3, Michalovce
Contract type
full-time
full-time
Start date
by agreement
by agreement
Wage (gross)
minimum 1100€ / monthly (depending on experiences and quality of the candidate) + quarterly bonus and other benefits in compliance with social benefit program of the company
minimum 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
Change Control Coordiantor effectively uses Scientific / Engineering knowledge and training combined with Quality Systems / Regulatory and GXP Requirements knowledge to support Existing and New Medical Devices and Product Development Projects in relation to the Change controlling.
Responsibilities:
• Applies Change Control and Documentation Control per 21 CFR Part 820, ISO 9001, and ISO 13485
• Ensure appropriate Change control mechanisms are developed and deployed effectively
• Provide guidance and support to all who work within Michalovce and Minsk (if required and related to Michalovce products) Change Control process
• Ensure compliance to the Global Change Control process through critical review of documentation suporting change requests
• Proactively identify areas of opportunity within Michalovce and provide reasonned solution for improvement
• Demonstrate a high level of organizational skills to meet business deadlines and company objectives while ensuring that quality systems and quality regulations are maintained
• Establish strong global relationships with key partners (internal and external ) and demonstrate accountability with focus on customer service
• Work on own initiative with minimal supervision while fostering and promoting a continuous improvement attitude and culture
• Maximize use of technical abilities and experiences to produce results of the highest class
• 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.
Powers:
• Manage diverse team of personnel in terms of leadership development
• Change and Documentation Control, reviewing approval of Change requests
• To carry on internal audits relating to documentation
• Training of employees on Change Control Process, EDMS - CEDAR and required standards
• Co-ordinates flow and awareness of the Change Control Processes among departments
Responsibilities:
• Applies Change Control and Documentation Control per 21 CFR Part 820, ISO 9001, and ISO 13485
• Ensure appropriate Change control mechanisms are developed and deployed effectively
• Provide guidance and support to all who work within Michalovce and Minsk (if required and related to Michalovce products) Change Control process
• Ensure compliance to the Global Change Control process through critical review of documentation suporting change requests
• Proactively identify areas of opportunity within Michalovce and provide reasonned solution for improvement
• Demonstrate a high level of organizational skills to meet business deadlines and company objectives while ensuring that quality systems and quality regulations are maintained
• Establish strong global relationships with key partners (internal and external ) and demonstrate accountability with focus on customer service
• Work on own initiative with minimal supervision while fostering and promoting a continuous improvement attitude and culture
• Maximize use of technical abilities and experiences to produce results of the highest class
• 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.
Powers:
• Manage diverse team of personnel in terms of leadership development
• Change and Documentation Control, reviewing approval of Change requests
• To carry on internal audits relating to documentation
• Training of employees on Change Control Process, EDMS - CEDAR and required standards
• Co-ordinates flow and awareness of the Change Control Processes among departments
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 data protection law.
Information about personal data processing of job seekers is located on link: http://www.convatec.sk/o-spolocnosti/kariera
Information about personal data processing of job seekers is located on link: http://www.convatec.sk/o-spolocnosti/kariera
Requirements for the employee
Candidates with education suit the position
Secondary with school-leaving examination
University education (Bachelor's degree)
University education (Master's degree)
University education (Bachelor's degree)
University education (Master's degree)
Personality requirements and skills
• Good written and spoken English
• Computer skills: MS Office, Word, Excel, Adobe Acrobat, Outlook, Statistical tools like Minitab
• SAP - prefered
• Knowledge of ISO 9000, ISO 13485, MDD, FDA regulations and regulatory principles with respect to Document Management, Knowledge of continuous improvement/ quality assurance methods and techniques
• Projects Management, participating on the projects
• Makes decisions guided by established policies and procedures
• Develops and implements solutions to a wide range of product or business needs
• Works in a multifunctional, multinational environment
• Familiarity of Change requests database
• Flexibility
• Independence
• Team player
• Organized person
• Good communication level
• Managerial, leadership skills
• Computer skills: MS Office, Word, Excel, Adobe Acrobat, Outlook, Statistical tools like Minitab
• SAP - prefered
• Knowledge of ISO 9000, ISO 13485, MDD, FDA regulations and regulatory principles with respect to Document Management, Knowledge of continuous improvement/ quality assurance methods and techniques
• Projects Management, participating on the projects
• Makes decisions guided by established policies and procedures
• Develops and implements solutions to a wide range of product or business needs
• Works in a multifunctional, multinational environment
• Familiarity of Change requests database
• Flexibility
• Independence
• Team player
• Organized person
• Good communication level
• Managerial, leadership skills
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: 3450779
Dátum zverejnenia: 16.7.2018
2018-07-16
lokalita: Priemyselný park 3, Michalovce Pozícia: Quality Engineer, Quality Inspector Spoločnosť: Unomedical s.r.o.
Základná zložka mzdy (brutto) a ďalšie odmeny: minimum 1100€ / monthly (depending on experiences and quality of the candidate) + quarterly bonus and other benefits in compliance with social benefit program of the company