Quality Systems Engineer II

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, incontinence care and infusion care. With around 10,000 colleagues, we provide our products and services in nearly 100 countries, united by a promise to be caring for good. Our solutions deliver a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Group revenues in 2023 exceeded $2 billion. The company is a constituent of the FTSE 100 index (LSE:CTEC). For more information on Convatec, please visit: http://www.convatecgroup.com

About the role

Facilitate that the design control process and Change control process are followed properly by writing and reviewing the documentation applicable.

Key Responsabilities:

•  Responsible for planning the order and dependencies on design control documentation according to project time plan, including transparency of completing the tasks.

• Responsible for creating and finalizing DDP, DI-TM, Technical design review plan & report.

• Responsible for recording and documenting the needed actions from TDRs, coordinate the actions and ensure action overview is prepared, reviewed and approved and any changes are controlled.

• Chair and facilitate technical design reviews (agenda and minutes).

• Conduct teaching and coaching during introduction or updates on procedures and instructions related to R&D design control.

Requirements:

• Bachelor’s degree in Industrial Engineering, Process Engineering or related careers.

• Approximately 3 years of experience in product development.

• Knowledge of requirements of FDA's QSR, GMP and ISO 13485 or similar regulations.

• English proficiency: Intermediate - Advanced.

• Desirable experience in Medical Device

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