Principal - Business Quality (Strategic Project QA Lead)
Unomedical s.r.o.
- Place of work: Priemyselný park 3, Michalovce
- Basic wage component (gross) and other rewards: 1 600 EUR/monthminimum 1600€ / monthly (depending on experiences and quality of the candidate) + quarterly bonus and other benefits in compliance with social benefit program of the company
- Start date: by agreement
- Contract type: full-time
Job description, responsibilities and duties
Pioneering trusted medical solutions to improve the lives we touch: Convatec 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 and critical care, and infusion care. With around 10,000 colleagues, and a promise to be forever caring, our products and services are available in over 100 countries. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. The company is a constituent of the FTSE 100 Index (LSE: CTEC) and in 2021 revenues were over $2 billion. To learn more about Convatec, please visit http://www.convatecgroup.com
At Convatec, we’re transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. We’re aiming for nothing short of excellence. Join us on our journey to #ForeverCaring as a Principal - Business Quality, and you’ll do the same.
About the role:
Effectively uses Scientific / Engineering knowledge and training combined with Quality Systems / Regulatory and GXP requirements knowledge to support Manufacturing of Medical Devices and the Continuous Improvement activities for the Manufacturing Processes and Execution of Projects.
Your key duties and responsibilities as a Principal - Business Quality:
New business:
• Lead NPD (New Product Development) projects from QA tasks/responsibilities point of view
• Lead implementation of Design requirements into manufacturing process. Approve design transfer
• Lead/Participate process FMEA (Failure Mode & Effects Analysis) for NPD
• Prepare/Support creation of Master Validation Plan for NPD
• Support Test method development, validation & transfer
• Ensure Test method implementation and training
Base business:
• Lead Strategic Quality Projects
• Ensure proper documentation of Quality Projects
• Support/Lead solving of serious product quality issues
• Identify areas of improvement / simplification
• Conduct internal and external audits
• Review and Approval of RCI (Root Cause Investigation) reports
• Supervise & Support Calibration process of equipment in the plant
• Assessment/Approval of CAPA (Corrective Action & Preventive Action) records
At Convatec, we’re transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. We’re aiming for nothing short of excellence. Join us on our journey to #ForeverCaring as a Principal - Business Quality, and you’ll do the same.
About the role:
Effectively uses Scientific / Engineering knowledge and training combined with Quality Systems / Regulatory and GXP requirements knowledge to support Manufacturing of Medical Devices and the Continuous Improvement activities for the Manufacturing Processes and Execution of Projects.
Your key duties and responsibilities as a Principal - Business Quality:
New business:
• Lead NPD (New Product Development) projects from QA tasks/responsibilities point of view
• Lead implementation of Design requirements into manufacturing process. Approve design transfer
• Lead/Participate process FMEA (Failure Mode & Effects Analysis) for NPD
• Prepare/Support creation of Master Validation Plan for NPD
• Support Test method development, validation & transfer
• Ensure Test method implementation and training
Base business:
• Lead Strategic Quality Projects
• Ensure proper documentation of Quality Projects
• Support/Lead solving of serious product quality issues
• Identify areas of improvement / simplification
• Conduct internal and external audits
• Review and Approval of RCI (Root Cause Investigation) reports
• Supervise & Support Calibration process of equipment in the plant
• Assessment/Approval of CAPA (Corrective Action & Preventive Action) records
Employee perks, benefits
• Quarterly bonus after the trial period - max. 10% from the monthly salary of the employee (based on the results of the production plant)
• Large corporation with representation and manufacturing plants in the world
• Stable employer for Michalovce city and its surroundings
• Corporate culture – Underpinning everything we do are our values:
- Improve care
- Deliver results
- Grow together
- Own it
- Do what´s right
• Convatec Day – extra day off
• Home office possibilities
• Flexible working hours
• Introduction program according to company standards
• Development trainings
• Career opportunities for internal employees
• Referral bonus system
• Recognition program
• Meals in the amount of 0.17 Eur per one meal unit / day
• Supplementary pension plan after the trial period with the employer's contribution
• Social fund (various support and perks for employees)
• Free bus transport within Michalovce city
• Various events / team building activities for employees (no pandemic situation)
• Various employee discounts by vendors within Michalovce city
• Large corporation with representation and manufacturing plants in the world
• Stable employer for Michalovce city and its surroundings
• Corporate culture – Underpinning everything we do are our values:
- Improve care
- Deliver results
- Grow together
- Own it
- Do what´s right
• Convatec Day – extra day off
• Home office possibilities
• Flexible working hours
• Introduction program according to company standards
• Development trainings
• Career opportunities for internal employees
• Referral bonus system
• Recognition program
• Meals in the amount of 0.17 Eur per one meal unit / day
• Supplementary pension plan after the trial period with the employer's contribution
• Social fund (various support and perks for employees)
• Free bus transport within Michalovce city
• Various events / team building activities for employees (no pandemic situation)
• Various employee discounts by vendors within Michalovce city
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 GDPR and data protection law.
Information about personal data processing of job seekers is located on link: http://www.convatec.sk/o-nás/kariéra/
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)
University education (Master's degree)
Educational Specialization
BSc or higher degree qualified in science / engineering
Language skills
English - Upper intermediate (B2)
Personality requirements and skills
About you:
• Experience gained within a Regulated Industry, preferable Medical Devices
• Demonstrated knowledge of Regulatory and GXP Compliance requirements, good knowledge of Design Controls, MDSAP (Medical Device Single Audit Program) requirements, Risk Management Process, CAPA and deviation handling
• Experience with Quality tools such as Quality Control Plans, Test Method validation and transfer, Statistics, Sampling, Root Cause Analysis, Process and product Validation, Experimental Designs, and Process Optimization
• Proactive and flexible in adapting to changing environment and able to manage and priorities work and competing objectives
• Ability to work and communicate in a cross-function, multinational environment working relationships and multi-cultural and diverse suppliers and contract manufacturers
• Good interpersonal skills and ability to influence people without direct authority
Education / Qualifications:
• BSc or higher degree qualified in science / engineering
• Demonstrated ability to analyze and interpret complex problems
• Must be proficient with PC programs, i.e. Office (Excel, Word, and PowerPoint), Statistical tools like Minitab or Jump, Project Management (Microsoft Project, etc.), SAP knowledge
• Six Sigma knowledge preferred
• Communicative level of English language
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.
#convatec #michalovce #slovakia #principalquality #projectqualitylead #quality #workthatwillmoveyou #ForeverCaring #ForeverConvatec #WeAreConvatec
• Experience gained within a Regulated Industry, preferable Medical Devices
• Demonstrated knowledge of Regulatory and GXP Compliance requirements, good knowledge of Design Controls, MDSAP (Medical Device Single Audit Program) requirements, Risk Management Process, CAPA and deviation handling
• Experience with Quality tools such as Quality Control Plans, Test Method validation and transfer, Statistics, Sampling, Root Cause Analysis, Process and product Validation, Experimental Designs, and Process Optimization
• Proactive and flexible in adapting to changing environment and able to manage and priorities work and competing objectives
• Ability to work and communicate in a cross-function, multinational environment working relationships and multi-cultural and diverse suppliers and contract manufacturers
• Good interpersonal skills and ability to influence people without direct authority
Education / Qualifications:
• BSc or higher degree qualified in science / engineering
• Demonstrated ability to analyze and interpret complex problems
• Must be proficient with PC programs, i.e. Office (Excel, Word, and PowerPoint), Statistical tools like Minitab or Jump, Project Management (Microsoft Project, etc.), SAP knowledge
• Six Sigma knowledge preferred
• Communicative level of English language
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.
#convatec #michalovce #slovakia #principalquality #projectqualitylead #quality #workthatwillmoveyou #ForeverCaring #ForeverConvatec #WeAreConvatec
Advertiser
Brief description of the company
Pioneering trusted medical solutions to improve the lives we touch: Convatec 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 and critical care, and infusion care. With around 10,000 colleagues, and a promise to be forever caring, our products and services are available in over 100 countries. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. The company is a constituent of the FTSE 100 Index (LSE: CTEC) and in 2021 revenues were over $2 billion. 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