Quality Engineer II

Responsibilities

• Apply quality engineering tools and techniques during the different phases of product development, product and process transfers, transfer design, process and product changes, and supplier management.
• Responsible for ensuring compliant implementation of new product and process development, product and process transfer, and product and process changes.
• Responsible for the development, validation, and transfer of test methods for new and existing products and processes.
• Responsible for conducting and managing problem solving sessions. Plan, schedule and coordinate phases of quality engineering projects.
• Responsible for developing Quality plans during the transfer of new products that includes, raw material, in-process and final product specifications, process and test method qualification, supplier capacity evaluation process, product design validation. and reliability strategies.
• Responsible for participating and supporting all activities related to Global Change Control, CAPA and Complaints processes.
• Provide support in process mapping, ensuring compliance with the Convatec Global Validation process, policy and guideline.
• Carry out risk management in new product support, transfer and development activities.
• Actively participates in improvement efforts for existing products, processes and service.
• Create and implement changes in Validation and Change Control programs, to improve compliance, reduce costs and improve customer service.
• Responsible for leading the periodic review program, ensuring compliance with the dates established in the procedures.
• Responsible for leading quality system monitoring and improvement activities.

Requirements

• Basic understanding and knowledge of Regulated Quality Systems as includes FDA/CE/ISO.
• Knowledge and understanding of the principles of product validation and qualification.
• The ability to effectively apply analytical and statistical techniques such as reliability evaluation models, Implementation of Quality Functions, Hypothesis Testing, repetition of events, costs, among others, is recommended.
• Some experience in applying risk management principles.
• Some experience working in an FDA regulated industry with at least a basic understanding of controls, validation processes, supplier management, quality planning.
• Train functional areas in engineering techniques and principles.
• Analyze and interpret problems and data, using problem-solving methodologies.
• Qualifications/Education:
• Degree, preferably in Engineering.
• 3 to 5 years of relevant work experience.
• Three (3) to Five (5) years of experience in documentation management and control is preferred.
• Principal Contacts & Purpose of Contact:
• Managers (internal/external) to exchange information, Engineers (internal/external) to support the different validation phases, Supervisors (internal).
• Travel Requirements
• Approximately 10% of your travel time is required to other plants, customers and or suppliers.
• Languages
• Speaking: Yes English
• Writing/Reading: Yes English
• Working Conditions
• Role A (100% in plant).
• EHS requirements are established in local procedures.
• The employee will not be exposed to any chemicals.
• Know CVT's EHS and OH policies and the standards that support them.
• Understand EHS risks and all requirements related to your job responsibilities and the appropriate controls in place to manage those risks and requirements.
• Perform job responsibilities professionally and in compliance with internal EHS requirements and procedures without compromising the safety of self or others.
• Be alert to EHS hazards in the workplace, responding to them appropriately and immediately reporting them to responsible management as soon as they are identified (for example, spills).
• Participate in EHS community, training, and awareness initiatives.
• Help drive permanent improvement of EHS performance, recommending potential improvements to responsible management.
• Special Factors
• Availability to work weekends, if required.
• Read

Additional Information

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 Position Overview: Responsible for applying Quality Engineering tools and techniques that ensure compliance during various phases of product/process development, product/process transfer, transfer designs, process, and product changes.

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