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Supplier Quality Engineer
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)
1 000 EUR/monthminimum 1000€ / monthly (depending on experiences and quality of the candidate) + quarterly bonus and other benefits in compliance with social benefit program of the company
1 000 EUR/monthminimum 1000€ / 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 9,000 employees and in 2019, our Group generated revenues of over $1.827 billion. To learn more about ConvaTec, please visit www.convatecgroup.com.
Our search for better is changing the lives of our customers. It’s changing the careers of our people too – creating new challenges and opportunities all the time. We’re a business that never stands still. Join us as a Supplier Quality Engineer, and you won’t either.
About the role:
This position supports the ConvaTec Supplier Quality Management group, which is responsible for ensuring that effective Quality Systems are in place at ConvaTec as well as supplier sites.
The Supplier Quality Engineer (QE) is expected to represent the Quality Function at all times, lead projects and teams with minimum supervision and guidance.
The Supplier Quality Engineer (QE) determines and develops approach to achieve specific goals and objectives, makes decisions guided by established policies and procedures, develops and implements solutions to a wide range of product or business needs, and works in a multifunctional, multinational environment and is capable of influencing with no direct authority.
The position is measured against compliance to internal and external regulations and established objectives aligned with the team and company.
Your key duties and responsibilities:
• Conducting and managing supplier assessments to determine the state of Quality Systems and process capabilities at supplier sites in support of ongoing business and new product introductions. Uses auditing as a proactive tool for improvement as well as compliance and challenges existing practice where appropriate
• Ensures supplier systems are aligned with current regulatory requirements, standards and ConvaTec policies and requirements
• Responsible for providing oversight for supplier assessments, escalating issues and leading risk assessments and mitigations as appropriate
• Collaborates with key business partners to drive supplier nonconformance investigations and define effective corrective actions
• Takes responsibility for the measuring and monitoring of supplier performance against agreed KPIs
• Collates and shares information / data through reports and follows up on identified improvement opportunities. Actively participates and / or drives site / Global Quality System improvements as required
• Acts as the quality subject matter expert on cross functional teams during suppler evaluation and selection activities and development of Supplier Quality Agreements
• Involved in the development and execution of the annual Supplier Audit plan
• Champions Risk Management activities through leadership, facilitation and active support during supplier evaluation and selection activities. Demonstrates courage to drive Risk Management in decision-making to determine sound and timely decisions that balance compliance, business and product performance
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 9,000 employees and in 2019, our Group generated revenues of over $1.827 billion. To learn more about ConvaTec, please visit www.convatecgroup.com.
Our search for better is changing the lives of our customers. It’s changing the careers of our people too – creating new challenges and opportunities all the time. We’re a business that never stands still. Join us as a Supplier Quality Engineer, and you won’t either.
About the role:
This position supports the ConvaTec Supplier Quality Management group, which is responsible for ensuring that effective Quality Systems are in place at ConvaTec as well as supplier sites.
The Supplier Quality Engineer (QE) is expected to represent the Quality Function at all times, lead projects and teams with minimum supervision and guidance.
The Supplier Quality Engineer (QE) determines and develops approach to achieve specific goals and objectives, makes decisions guided by established policies and procedures, develops and implements solutions to a wide range of product or business needs, and works in a multifunctional, multinational environment and is capable of influencing with no direct authority.
The position is measured against compliance to internal and external regulations and established objectives aligned with the team and company.
Your key duties and responsibilities:
• Conducting and managing supplier assessments to determine the state of Quality Systems and process capabilities at supplier sites in support of ongoing business and new product introductions. Uses auditing as a proactive tool for improvement as well as compliance and challenges existing practice where appropriate
• Ensures supplier systems are aligned with current regulatory requirements, standards and ConvaTec policies and requirements
• Responsible for providing oversight for supplier assessments, escalating issues and leading risk assessments and mitigations as appropriate
• Collaborates with key business partners to drive supplier nonconformance investigations and define effective corrective actions
• Takes responsibility for the measuring and monitoring of supplier performance against agreed KPIs
• Collates and shares information / data through reports and follows up on identified improvement opportunities. Actively participates and / or drives site / Global Quality System improvements as required
• Acts as the quality subject matter expert on cross functional teams during suppler evaluation and selection activities and development of Supplier Quality Agreements
• Involved in the development and execution of the annual Supplier Audit plan
• Champions Risk Management activities through leadership, facilitation and active support during supplier evaluation and selection activities. Demonstrates courage to drive Risk Management in decision-making to determine sound and timely decisions that balance compliance, business and product performance
Information about the selection process
Please send your CV only in English language.
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/
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)
Postgraduate (Doctorate)
University education (Master's degree)
Postgraduate (Doctorate)
Language skills
English - Upper intermediate (B2)
Personality requirements and skills
About you:
• 3 to 5 years’ experience in Pharmaceutical, Medical Devices or OTC Drugs required
• Demonstrated knowledge of Regulatory and GXP Compliance requirements such as ISO 9001 / ISO 13485, QSR Part 820, MDD 93/42, GMP Parts 210 and 211.
• In depth knowledge of Supplier Quality Management principles, including auditing and problem solving skills required
• Solid knowledge and experience of validation, nonconformance and CAPA systems, investigations and production and process controls is required
• Demonstrated knowledge and experience of Risk Management and the application and use of Risk Management Tools such as FMEA, Process Mapping, Hazard Analysis.
• Logical Thinking Skills and Experience: demonstrated ability to analyze and interpret complex problems / data gathered from a variety of sources
• Demonstrated ability to effectively work and communicate in a cross-function, multinational environment building co-operative working relationships. Demonstrated ability to work effectively with multi-cultural and diverse suppliers and contract manufacturers.
• Good interpersonal skills and ability to influence people without direct authority.
• Proactive and flexible in adapting to changing environment and able to manage and prioritize work and competing objectives.
• Hands on experience and knowledge of cGMP manufacturing of Pharmaceutical/Drug (OTC) and cosmetics - Desirable but not required
Education / Qualifications:
• BS or higher degree qualified in Science or Engineering
• Quality Auditor or Lead Auditor certification - Preferred
• English language - 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.
• 3 to 5 years’ experience in Pharmaceutical, Medical Devices or OTC Drugs required
• Demonstrated knowledge of Regulatory and GXP Compliance requirements such as ISO 9001 / ISO 13485, QSR Part 820, MDD 93/42, GMP Parts 210 and 211.
• In depth knowledge of Supplier Quality Management principles, including auditing and problem solving skills required
• Solid knowledge and experience of validation, nonconformance and CAPA systems, investigations and production and process controls is required
• Demonstrated knowledge and experience of Risk Management and the application and use of Risk Management Tools such as FMEA, Process Mapping, Hazard Analysis.
• Logical Thinking Skills and Experience: demonstrated ability to analyze and interpret complex problems / data gathered from a variety of sources
• Demonstrated ability to effectively work and communicate in a cross-function, multinational environment building co-operative working relationships. Demonstrated ability to work effectively with multi-cultural and diverse suppliers and contract manufacturers.
• Good interpersonal skills and ability to influence people without direct authority.
• Proactive and flexible in adapting to changing environment and able to manage and prioritize work and competing objectives.
• Hands on experience and knowledge of cGMP manufacturing of Pharmaceutical/Drug (OTC) and cosmetics - Desirable but not required
Education / Qualifications:
• BS or higher degree qualified in Science or Engineering
• Quality Auditor or Lead Auditor certification - Preferred
• English language - 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!
To find out more please visit https://careers.convatec.com - thanks for your interest!
Number of employees
500-999 employees
Contact
ID: 3998080
Posting date: 18.1.2021
2021-01-18
location: Michalovce Position: Process Engineer, Quality Engineer, Quality Inspector, Quality Planner Company: Unomedical s.r.o.
Basic salary component (gross): 1 000 EUR/month