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Associate Post Market 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.
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 an Associate Post Market Quality Engineer, and you’ll drive progress that really means something.
About the role:
The Assocate Post Market Quality Engineer executes quality engineering deliverables required within the post market compliance & surveillance processes.
Timely and accurate presentation of complaint analysis to all stakeholders, while concurrently leading root cause analysis for any issues identified.
Provides data aggregation and administrative support for processes for collection and maintenance of post market data.
Your key duties and responsibilities:
• Support quality engineering activities for all post market product surveillance including collection, analysis, and evaluation of product safety and performance data, and detection of trends in data that may warrant further action
• Execute and maintain procedures and processes to address post-market surveillance activities such data aggregation, collection and maintenance
• Develop understanding of the current risk profile for all products including reportable product harms and malfunctions
• Participate in design control activities and provide input into identifying failure modes and risk assessment for new and existing products while providing expertise in product complaint history and occurrence levels
• Support investigations arising from CAPA, complaints, Health Hazard Evaluations (HHE), Internal audits, third party inspections, and other business processes by applying typical quality/problem solving tools such as fishbone/cause & effect, Pareto, process mapping, etc.
• Support continuous improvement of quality engineering procedures, processes, and tools
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.
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 an Associate Post Market Quality Engineer, and you’ll drive progress that really means something.
About the role:
The Assocate Post Market Quality Engineer executes quality engineering deliverables required within the post market compliance & surveillance processes.
Timely and accurate presentation of complaint analysis to all stakeholders, while concurrently leading root cause analysis for any issues identified.
Provides data aggregation and administrative support for processes for collection and maintenance of post market data.
Your key duties and responsibilities:
• Support quality engineering activities for all post market product surveillance including collection, analysis, and evaluation of product safety and performance data, and detection of trends in data that may warrant further action
• Execute and maintain procedures and processes to address post-market surveillance activities such data aggregation, collection and maintenance
• Develop understanding of the current risk profile for all products including reportable product harms and malfunctions
• Participate in design control activities and provide input into identifying failure modes and risk assessment for new and existing products while providing expertise in product complaint history and occurrence levels
• Support investigations arising from CAPA, complaints, Health Hazard Evaluations (HHE), Internal audits, third party inspections, and other business processes by applying typical quality/problem solving tools such as fishbone/cause & effect, Pareto, process mapping, etc.
• Support continuous improvement of quality engineering procedures, processes, and tools
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:
• At least 1 year experience in quality engineering role in a medical device or life sciences technology driven company
• Knowledge of various phases of the product development lifecycle including concept, design, implementation, verification, and validation activities necessary for product commercialization
• Knowledge of product and process risk management
• Experience in post-market surveillance activities (tracking and trending, investigations, complaints)
• Knowledge in quality systems and medical devices: QSR Part 820, ISO 13485, MDD 93/42, GMP Parts 201 and 211
• Proficiency in MS Visio, Minitab and MS Project
• High level of personal and professional integrity and trustworthiness with strong work ethic
• Ability to work independently with minimal direction, while producing quality work with a high level of accuracy and attention to detail
• Ability to maintain composure and focus while managing multiple priorities, changing workloads, and meeting critical deadlines
• Excellent communication, presentation, and facilitation skills
• Ability to work effectively within cross-functional team environments
• Support a positive working environment that encourages creative thinking and intelligent decision-making
• Proficient with general office software such as Word, Power Point, and Project, as well as statistical tools (e.g. Minitab)
• MS Excel skills, including the ability to independently create and utilize pivot tables, formulas, V-lookups, and other advanced data manipulation
• Passion for ongoing product and compliance learning as well as skills enhancement
Education / Qualifications:
• BS/BA degree in engineering or life sciences
• MS Excel skills, including the ability to independently create and utilize pivot tables and charts, formulas, V-lookups, and other advanced data manipulation
• English language - Upper intermediate (B2)
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.
• At least 1 year experience in quality engineering role in a medical device or life sciences technology driven company
• Knowledge of various phases of the product development lifecycle including concept, design, implementation, verification, and validation activities necessary for product commercialization
• Knowledge of product and process risk management
• Experience in post-market surveillance activities (tracking and trending, investigations, complaints)
• Knowledge in quality systems and medical devices: QSR Part 820, ISO 13485, MDD 93/42, GMP Parts 201 and 211
• Proficiency in MS Visio, Minitab and MS Project
• High level of personal and professional integrity and trustworthiness with strong work ethic
• Ability to work independently with minimal direction, while producing quality work with a high level of accuracy and attention to detail
• Ability to maintain composure and focus while managing multiple priorities, changing workloads, and meeting critical deadlines
• Excellent communication, presentation, and facilitation skills
• Ability to work effectively within cross-functional team environments
• Support a positive working environment that encourages creative thinking and intelligent decision-making
• Proficient with general office software such as Word, Power Point, and Project, as well as statistical tools (e.g. Minitab)
• MS Excel skills, including the ability to independently create and utilize pivot tables, formulas, V-lookups, and other advanced data manipulation
• Passion for ongoing product and compliance learning as well as skills enhancement
Education / Qualifications:
• BS/BA degree in engineering or life sciences
• MS Excel skills, including the ability to independently create and utilize pivot tables and charts, formulas, V-lookups, and other advanced data manipulation
• English language - Upper intermediate (B2)
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.
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: 3998088
Megjelentetés dátuma: 18.1.2021
2021-01-18
Régió: Michalovce Pozíció: Process Engineer, Quality Engineer, Quality Inspector, Quality Planner Cég: Unomedical s.r.o.
Alapbér (bruttó): 1 000 EUR/month