Senior Engineer - Business Quality

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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 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


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

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Cudzie jazyky

anglický - pokročilá: B1 a B2