Senior Supplier Quality Engineer – Injection Molding

Senior Supplier Quality Engineer – Injection Molding

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 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit Convatec.

At Convatec, we’re transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. We’re aiming for nothing short of excellence. Join us on our journey to #ForeverCaring as a Senior Supplier Quality Engineer – Injection Molding, and you’ll do the same.

About the role:

The Senior Supplier Quality Engineer – Injection Molding identifies, leads, and executes large scale complex and strategic projects and improvements with regards to Injection molding. Furthermore, the Senior Supplier Quality Engineer – Injection Molding is the recognized subject matter expert in the management and auditing of injection molding and resin suppliers to Convatec.

The role is focused on being the Global Supplier Quality point of contact for projects and management of activities relating to injection molding for Convatec’s Infusion Care business unit, driving forward improvement.

The job holder will not only demonstrate, but also support establishing the highest Quality standards and will embrace/drive Convatec core mission, values, and priorities.

Your key duties and responsibilities:

• Provides leadership as subject matter expert in Injection Molding, Statistical Sampling, Quality Sampling, CTQ Characterization, Risk Management activities, mold maintenance, and statistical process controls at supplier sites including mold maintenance.
• Lead and provide input into global quality standards and policies regarding supplier quality performance and supplier selection process, ensuring compliance with industry and regulatory standards.
• Conduct Supplier audits related to injection molding, mold or resin suppliers during the onboarding process and lifecycle of supplier relationships as per the Global Supplier Quality Schedule.
• Drives significant change requests through to closure for our CCR process.
• Works with R&D on improving CTQ requirements for the current product portfolio and NPD projects relating to injection molding.
• Support maintaining and developing a robust incoming inspection process related to injection molded parts.
• Collates and shares information/data through reports and follows up on identified improvement opportunities related to injection molding.
• Actively participates and/or drives Quality System improvements as required.
• Manages complex supplier manufacturing Investigations relating to suppliers’ issues through the SCAR and CAPA process.
• Demonstrates high commitment to quality and customer service based on customer needs.
• Build strong relationships with customers, suppliers, senior stakeholders, and support groups worldwide to meet the demands of a changing business environment.
• Coaches, reviews, and appropriately delegates work with lower-level professionals.
• Demonstrates strong technical knowledge and principles in relation to injection molding medical devices in line with ISO13485 ISO9001 GMP Parts 201 and 211, EU MDR.
• In collaboration with procurement and R&D, identify, manage, and develop injection molding, resin, and mold suppliers according to established organization quality standards and policies.
• Represent Convatec as a subject matter expert for injection molding, resins, and molds for Global Supplier Quality in general and during internal and external body audits.
• Support the maintenance of Convatec’s Global Supplier Quality program, whilst driving opportunities for improvement.
• Leads, identifies, and establishes processes and measures for maintaining, and improving supplier performance metrics, policies, and procedures in administering quality relationships with suppliers.
• Actively resolves Supplier related issues associated with quality or poor performance to supplier performance metrics.
• Work autonomously in alignment with defined process and ways of working.
• Collaborates with the procurement and R&D teams to identify and certify new and/or alternative suppliers/manufacturers to mitigate supply risks or support new product launches.
• Use and promote the benefits of structured and standardized Lean / Six Sigma / KT methodology for process improvement and development.
• Leads and manages large-scale projects or processes relating to injection molding, resins, and molds on behalf of Global Supplier Quality.
• Raise appropriate questions or concerns regarding regulatory compliance to appropriate authorities regarding Purchasing Control activities.
• Quality Subject Matter Expert support with R&D and to complete trials, Technical & Statistical studies such as MSA, VSM, and Gage R-R at suppliers, including introduction of new resins and injection molds.

Skills & Experience:

• Minimum of 5 years’ experience in injection molding.
• An end-to-end perspective in creating high-quality molds.
• Experience in defining CTQ requirements and incoming inspection requirements.
• Experience using and reviewing 3D CAD system and technical drawings.
• Preferably minimum 2 years of experience in the medical device industry.
• Minimum 3 years of experience in Supplier Quality Control.
• Experience in internal and supplier related CAPA/ NC/ SCAR initiation.
• Knowledge of ISO 9001, and preferably ISO13485 and FDA medical requirements.
• Strong statistical, analytical, and problem-solving skills.
• Proficiency in quality tools and methodologies, such as Six Sigma, FMEA, and SPC.
• Strong prioritization and coordination skills.
• Ability to work with electronic databases (i.e. Documentum, Trackwise, SAP).
• Advanced computer management skills including Microsoft Word, Excel, and Visio.
• Proactivity and flexibility to meet priorities and achieve deliverables.
• Ability to operate autonomously, negotiate, and partner with internal and external customers to enhance operational effectiveness.

Qualifications/Education:

• BS or higher degree qualified in Science or Mechanical Engineering or Plastics Technology.
• Quality Auditor or Lead Auditor certification in ISO9001 or ISO13485.
• Lean Six Sigma Greenbelt is preferable.

Travel Requirements:

• The position may involve travel up to 25% of the time to Convatec sites and supplier locations globally.

Working Conditions:

• Fixed-term contract for a duration of 2 years with remote work setting, presence at the local or global offices may be required based on in-country legal requirements and for specific meeting, projects, and events.

Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen, too. It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it.

This is stepping up to a challenge.

This is work that’ll move you.