Product Quality Engineer

About Convatec

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 more than 10,000 colleagues, we provide our products and services in around 90 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. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com

The role:

The QC-specialist is responsible of the quality activities including but not limited to inspections/audits, qualification, monitoring, corrective and preventive actions, SCAR´s among others.

Responsibilities:

• Maintain QMS documentation.
• Ensure timely handling of NC/CAPAs, perform containment activities of nonconforming raw materials, sub-assemblies, and finished products both physically and electronically (including Stop Shipment) and disposition activities.
• Create and handle SCARs.
• Support local departments in Denmark, BU IC and at our Mexico, UMD MX site in matters regarding raw materials, semi-finished and finished products.
• Facilitate and participate in continuous improvement and optimization of the working routines.
• Participate in audits.
• Support incoming inspection according to applicable QMS documents.
• Support batch release according to applicable QMS documents.
• Training of colleagues in relevant tasks.
• Execute reporting and trend analysis related to quality.
• Participate in Supplier Audit according to schedule.
• Manage and follow up corresponding to Quality specifications with the suppliers as applicable.
• Work with the supplier and procurement teams to solve any issue that may affect quality and products.
• Support and participate in company projects
• Implement Procedures, and work instructions to support supplier controls in QMS.
• Lead and or support, when applicable, audits and certification.
• Participate as represented for QC.

Skills & Experience:

• Working in the medical device industry and regulatory requirements including QSR, ISO 13485, or in Pharma/business that are quality regulated.
• Strong and effective presentation skills for business cases, written documents, and interpersonal communications
• Has participated (either in back or front room) in inspection by regulating entities (e.g. FDA, Anvisa, ISO).
• Ability to work with other areas and other sites.
• Ability to handle high pressure situations.
• Strong English written and verbal skills, required.
• Experienced computer skills

Qualifications/Education:

• Degree in science, Engineering and or business administration.
• Knowledge and execution of CAPAs, Complaints and process associated with them.
• Knowledge and understanding of validations and qualifications principles.
• Has project lead experience.

Languages
Speaking: Yes English*
Writing/Reading: Yes English*

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