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Product Quality Engineer (Sustaining Engineering Group)
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)
950 EUR/monthminimum 950€ / monthly (depending on experiences and quality of the candidate) + quarterly bonus and other benefits in compliance with social benefit program of the company
950 EUR/monthminimum 950€ / 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
• Representing Quality Management, actively contributes to the development of New Products within the new product development process. Responsible for ensuring that Design Control requirements including development of Design and Development plans meet regulatory and applicable procedural requirements. Responsible for reviewing and approving design control document outputs. Works closely with Manufacturing Quality Engineers to assure appropriate Validation Planning and a robust Design Transfer.
• Uses technical and GXP knowledge to influence and assure Quality and Compliance in Design and develops plans for Post Launch / lifecycle management activities.
• Provides leadership as subject expert in Design Control and actively supports and influences development teams in the translation of User Needs to Design Inputs, Design Outputs, Design Verification and Design Validation activities, and timely Design Reviews. Develops and assures that Quality Control Plans are complete and meet the standards and requirements appropriate for the type of product.
• Champions Risk Management activities through leadership, facilitation and active support during Product Development, and Post Launch Change Control activities. Demonstrates courage to drive Risk Management in decision-making to determine sound and timely decisions that balance compliance, business and product performance.
• Responsible for Post Launch Reviews. Investigates product / process performance issues and leads or participates in multifunctional evaluation of products in the market. Evaluates data using statistical tools. Leads or support Complaint investigations through Root Cause Analysis and effective Corrective or Preventive Actions (CAPA). Leads or actively supports Product Change Control.
• Performs internal and supplier process audits as required to support business. Uses auditing as a proactive tool for improvement as well as compliance and challenges existing practice where appropriate.
• Takes responsibility for the measuring and monitoring of performance against agreed KPIs. Collates and shares information / data through reports and follows up on identified improvement opportunities. Actively participates and / or drives site /Company wide Quality System improvements as required.
• Uses technical and GXP knowledge to influence and assure Quality and Compliance in Design and develops plans for Post Launch / lifecycle management activities.
• Provides leadership as subject expert in Design Control and actively supports and influences development teams in the translation of User Needs to Design Inputs, Design Outputs, Design Verification and Design Validation activities, and timely Design Reviews. Develops and assures that Quality Control Plans are complete and meet the standards and requirements appropriate for the type of product.
• Champions Risk Management activities through leadership, facilitation and active support during Product Development, and Post Launch Change Control activities. Demonstrates courage to drive Risk Management in decision-making to determine sound and timely decisions that balance compliance, business and product performance.
• Responsible for Post Launch Reviews. Investigates product / process performance issues and leads or participates in multifunctional evaluation of products in the market. Evaluates data using statistical tools. Leads or support Complaint investigations through Root Cause Analysis and effective Corrective or Preventive Actions (CAPA). Leads or actively supports Product Change Control.
• Performs internal and supplier process audits as required to support business. Uses auditing as a proactive tool for improvement as well as compliance and challenges existing practice where appropriate.
• Takes responsibility for the measuring and monitoring of performance against agreed KPIs. Collates and shares information / data through reports and follows up on identified improvement opportunities. Actively participates and / or drives site /Company wide Quality System improvements as required.
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 data protection law.
Information about personal data processing of job seekers is located on link: http://www.convatec.sk/o-spolocnosti/kariera
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
Requirements for the employee
Candidates with education suit the position
University education (Master's degree)
Postgraduate (Doctorate)
Postgraduate (Doctorate)
Educational Specialization
in Science or Engineering
Language skills
English - Upper intermediate (B2)
Number of years of experience
3
Personality requirements and skills
• Degree or proven experience in science / engineering.
• Experience gained within a Regulated Industry, preferable Medical Devices.
• Demonstrated knowledge of Regulatory and ISO Compliance requirements. Good knowledge of Design Controls.
• Demonstrated knowledge and experience of Risk Management and the application and use of Risk Management Tools such as FMEA, Process Mapping, Hazard Analysis. ISO 14971
• Experience with Quality tools such as Quality Control Plans, Test Method validation and transfer, Statistics, Experimental Designs, Root Cause Analysis, Process validation, Process Optimization.
• Logical Thinking Skills and Experience: demonstrated ability to analyze and interpret complex problems / data gathered from a variety of sources and utilize.
• 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.
• Statistical knowledge, experience is desirable
• Six Sigma knowledge, experience and certification is preferable
• Advantage of experience of plastics, extrusion, injection moulding, assembly, bonding.
• Must be proficient with PC programs, statistical tools (e.g. Minitab) and MS Project and SAP knowledge is advantage
• Experience gained within a Regulated Industry, preferable Medical Devices.
• Demonstrated knowledge of Regulatory and ISO Compliance requirements. Good knowledge of Design Controls.
• Demonstrated knowledge and experience of Risk Management and the application and use of Risk Management Tools such as FMEA, Process Mapping, Hazard Analysis. ISO 14971
• Experience with Quality tools such as Quality Control Plans, Test Method validation and transfer, Statistics, Experimental Designs, Root Cause Analysis, Process validation, Process Optimization.
• Logical Thinking Skills and Experience: demonstrated ability to analyze and interpret complex problems / data gathered from a variety of sources and utilize.
• 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.
• Statistical knowledge, experience is desirable
• Six Sigma knowledge, experience and certification is preferable
• Advantage of experience of plastics, extrusion, injection moulding, assembly, bonding.
• Must be proficient with PC programs, statistical tools (e.g. Minitab) and MS Project and SAP knowledge is advantage
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: 3608463
Posting date: 14.11.2019
2019-11-14
location: Michalovce Position: Quality Engineer Company: Unomedical s.r.o.
Basic salary component (gross): 950 EUR/month