Senior Engineer - Business Quality (Senior Quality Compliance 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)
1 800 EUR/monthminimum 1800€ / monthly (depending on experiences and quality of the candidate) + annual global incentive plan-bonus and other benefits in compliance with social benefit program of the company
1 800 EUR/monthminimum 1800€ / monthly (depending on experiences and quality of the candidate) + annual global incentive plan-bonus and other benefits in compliance with social benefit program of the company
Information about the position
Job description, responsibilities and duties
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 on our journey to #ForeverCaring as a Senior Engineer – Business Quality, and you’ll drive progress that really means something.
About the role:
As a Senior Engineer – Business Quality you will be responsible of maintaining high quality standards for the product manufacturing and compliance with all applicable regulatory requirements. The scope is focused on Quality Compliance processes and is assured via the execution of the Corporate Quality Compliance Programs.
Your key duties and responsibilities as a Senior Engineer – Business Quality:
Internal Audit Process:
• Execute the Internal Audit Process in the organization according to the site schedule
• The position provides leadership, oversight, and strategic guidance for site issues related to Quality Compliance
• Ensure that the Quality Management System is periodically evaluated and audited and appropriate CAPA is taken to meet the business and regulatory requirements
• Ensure robust investigation of Audit Observations and adequate CAPA action plans, ensure alignment in Audit Non Conformance Ratings
• Liaise with Site Leaders on assessing gaps and defining actions plans related to Internal Audit Non Conformances
• Analyse Internal Audit data for systemic trends, drive compliance and improvement in Internal Audit Metrics
• Gather and analyse data as an input to the Management Reviews to allow meaningful review
• Support Internal Audit and Corporate Audits as required
External Audit Process:
• External audit process execution, from readiness, to execution, response and tracking of commitments
• Provides leadership, oversight, and strategic guidance for companywide issues related to Quality compliance
• Liaise with Quality Leaders on assessing gaps and defining actions plans related to External Audit Non-Conformances, reviewing and approving responses to Notified Body/Health Authorities as applicable
• Gather and analyse data as an input to the Management Reviews and/or CAPA Review Board
Compliance and Education Program:
• Contribute to the development of Corporate training materials to execute the Internal Audit Program and compliance education trainings (QSR, ISO, GMPs)
• Coach/train internal auditors
• Keep abreast of all current regulatory and statutory expectations
• Support Regulation/Standard Gap Assessments and implementation as required
Inspection readiness:
• Enable successful product realization and compliance through readiness compliance activities, assessments, and other consultation
• Ensure sites are in permanent state of inspection readiness using readiness tools
• Support coordination of responses to Notified Bodies to ensure SME and Management engagement and buy-in
• Performs and lead Gemba walks as part of readiness activities
Health Authority:
• Support External Audits and responses
Other responsibilities:
• Support other projects as required by the business
Join us on our journey to #ForeverCaring as a Senior Engineer – Business Quality, and you’ll drive progress that really means something.
About the role:
As a Senior Engineer – Business Quality you will be responsible of maintaining high quality standards for the product manufacturing and compliance with all applicable regulatory requirements. The scope is focused on Quality Compliance processes and is assured via the execution of the Corporate Quality Compliance Programs.
Your key duties and responsibilities as a Senior Engineer – Business Quality:
Internal Audit Process:
• Execute the Internal Audit Process in the organization according to the site schedule
• The position provides leadership, oversight, and strategic guidance for site issues related to Quality Compliance
• Ensure that the Quality Management System is periodically evaluated and audited and appropriate CAPA is taken to meet the business and regulatory requirements
• Ensure robust investigation of Audit Observations and adequate CAPA action plans, ensure alignment in Audit Non Conformance Ratings
• Liaise with Site Leaders on assessing gaps and defining actions plans related to Internal Audit Non Conformances
• Analyse Internal Audit data for systemic trends, drive compliance and improvement in Internal Audit Metrics
• Gather and analyse data as an input to the Management Reviews to allow meaningful review
• Support Internal Audit and Corporate Audits as required
External Audit Process:
• External audit process execution, from readiness, to execution, response and tracking of commitments
• Provides leadership, oversight, and strategic guidance for companywide issues related to Quality compliance
• Liaise with Quality Leaders on assessing gaps and defining actions plans related to External Audit Non-Conformances, reviewing and approving responses to Notified Body/Health Authorities as applicable
• Gather and analyse data as an input to the Management Reviews and/or CAPA Review Board
Compliance and Education Program:
• Contribute to the development of Corporate training materials to execute the Internal Audit Program and compliance education trainings (QSR, ISO, GMPs)
• Coach/train internal auditors
• Keep abreast of all current regulatory and statutory expectations
• Support Regulation/Standard Gap Assessments and implementation as required
Inspection readiness:
• Enable successful product realization and compliance through readiness compliance activities, assessments, and other consultation
• Ensure sites are in permanent state of inspection readiness using readiness tools
• Support coordination of responses to Notified Bodies to ensure SME and Management engagement and buy-in
• Performs and lead Gemba walks as part of readiness activities
Health Authority:
• Support External Audits and responses
Other responsibilities:
• Support other projects as required by the business
Employee perks, benefits
• Annual global incentive plan-bonus
• 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:
• 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
• 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
• 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
• Various employee discounts by vendors within Michalovce city
Information about the selection process
Note: 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)
University education (Master's degree)
Educational Specialization
Minimum of B.S., or equivalent, in a scientific/technical discipline is required
Language skills
English - Upper intermediate (B2)
Personality requirements and skills
About you:
• Internal Lead Auditor Certification and experience in executing audits
• Excellent written and verbal communication skills, with an open, collaborative, interactive leadership style
• Ability to build and nurture strong and positive relationships with other leaders to partner effectively
• Balanced technical understanding of products and processes combined with business and compliance acumen
Education / Qualifications:
• Minimum of B.S., or equivalent, in a scientific/technical discipline is required.
• Five to Ten (5-10) years in the medical device and/or pharmaceutical industry preferred.
• We welcome candidates with experience in Manufacturing, Validation, and Quality roles within the Medical Devices sector, who possess a willingness to develop Compliance skills.
• Two to Four (2-4) years’ experience in a QA/QC role.
• Practical experience and global mastery in global quality standards and regulations governing medical products.
• Communicative level of English language
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: 4680349
Dátum zverejnenia: 4.4.2024
2024-04-04
lokalita: Michalovce Pozícia: Quality Control/ISO Manager, Quality Engineer, Quality Inspector, Quality Planner Spoločnosť: Unomedical s.r.o.
Základná zložka mzdy (brutto): 1 800 EUR/month