Senior Supplier Quality Engineer – Injection Molding

ConvaTec Group; Colombes; À distance; EUR 50 000 - 90 000; Plein temps

Résumé du poste

An established industry player is seeking a Senior Supplier Quality Engineer specializing in injection moulding. In this pivotal role, you will lead strategic projects, manage supplier relationships, and ensure compliance with high-quality standards in the medical device sector. Your expertise will drive improvements and innovations, making a significant impact on patient care. Join a forward-thinking company dedicated to excellence and quality, where your contributions will be valued and recognized. If you are passionate about quality engineering and eager to make a difference, this opportunity is for you.

Prestations

Remote Work Options

Flexible Working Hours

Professional Development Opportunities

Health Insurance

Retirement Savings Plan

Employee Assistance Program

Paid Time Off

Travel Opportunities

Qualifications

• 5+ years in injection moulding with strong expertise in quality control.
• Experience with CAPA, NC, and SCAR processes in a medical device context.
• Proven ability to develop and maintain quality standards and policies.

Responsabilités

• Lead injection moulding projects and conduct supplier audits.
• Collaborate with R&D to improve quality requirements and support new products.
• Manage supplier quality issues and drive process improvements.

Connaissances

Injection Moulding

Quality Sampling

Statistical Process Control

Risk Management

CAPA

Six Sigma

Analytical Skills

Problem-Solving Skills

Formation

BSc in Science

Mechanical Engineering

Plastics Technology

Certified Lead Auditor in ISO 9001 or ISO 13485

Outils

3D CAD Systems

SAP

Trackwise

Documentum

MS Office

Description du poste

Senior Supplier Quality Engineer – Injection Moulding

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Senior Supplier Quality Engineer – Injection Moulding

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Join to apply for the Senior Supplier Quality Engineer – Injection Moulding role at Convatec

Convatec is a global medical products and technologies company focused on solutions for managing chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 employees, we operate in nearly 100 countries, committed to being forever caring. Our solutions aim to improve patient outcomes, prevent infections, and reduce care costs. In 2024, our revenues exceeded $2 billion. We are part of the FTSE 100 Index (LSE:CTEC). For more information, visit our website.

At Convatec, we strive for excellence in products, processes, and customer service. Join us as a Senior Supplier Quality Engineer – Injection Moulding and contribute to our mission of #ForeverCaring.

About the role:

The Senior Supplier Quality Engineer – Injection Moulding leads and executes strategic projects related to injection moulding. They are the subject matter expert in managing and auditing injection moulding and resin suppliers for ConvaTec. The role is the global point of contact for injection moulding projects within the Infusion Care business unit, driving improvements and maintaining high quality standards.

Your key duties and responsibilities:

• Provide expertise in Injection Molding, Statistical Sampling, Quality Sampling, CTQ Characterization, Risk Management, mold maintenance, and statistical process controls at supplier sites.
• Develop and maintain global quality standards and policies for supplier performance and selection, ensuring compliance with industry and regulatory standards.
• Conduct supplier audits for injection molding, mold, or resin suppliers during onboarding and throughout the supplier relationship lifecycle.
• Drive change requests through the CCR process.
• Collaborate with R&D to improve CTQ requirements and support NPD projects involving injection molding.
• Maintain and develop incoming inspection processes for injection molded parts.
• Share data and reports on injection molding performance and improvement opportunities.
• Participate in or lead quality system improvements.
• Manage complex investigations related to supplier issues via SCAR and CAPA processes.
• Demonstrate commitment to quality and customer service.
• Build strong relationships with customers, suppliers, and stakeholders globally.
• Coach and delegate work to team members.
• Apply technical knowledge of injection molding medical devices in line with ISO13485, ISO9001, GMP Parts 201 and 211, and EU MDR standards.
• Identify, qualify, and develop injection molding, resin, and mold suppliers in collaboration with procurement and R&D.
• Represent ConvaTec as a subject matter expert during audits.
• Support and improve ConvaTec’s Global Supplier Quality program.
• Establish and monitor supplier performance metrics and policies.
• Resolve supplier quality issues proactively.
• Work independently following established processes.
• Collaborate with procurement and R&D on supplier qualification for new products or supply risk mitigation.
• Promote Lean, Six Sigma, and KT methodologies for process improvements.
• Lead large-scale projects related to injection molding, resins, and molds.
• Address regulatory compliance concerns with relevant authorities.
• Support R&D with technical and statistical studies, including trials with new resins and molds.

Skills & Experience:

• At least 5 years’ experience in injection moulding.
• Experience in creating high-quality molds from end-to-end.
• Knowledge of CTQ requirements and incoming inspection processes.
• Proficiency with 3D CAD systems and technical drawings.
• Preferably 2+ years in the medical device industry.
• Minimum 3 years in Supplier Quality Control.
• Experience with CAPA, NC, SCAR processes.
• Knowledge of ISO 9001, ISO 13485, and FDA requirements.
• Strong analytical, statistical, and problem-solving skills.
• Proficiency with quality tools like Six Sigma, FMEA, SPC.
• Excellent prioritization and coordination skills.
• Ability to work with databases such as SAP, Trackwise, Documentum.
• Advanced MS Office skills.
• Proactive, flexible, and autonomous work style.

Qualifications/Education:

• BSc or higher in Science, Mechanical Engineering, or Plastics Technology.
• Certified Lead Auditor in ISO 9001 or ISO 13485.
• Lean Six Sigma Green Belt preferred.

Travel Requirements:

Up to 25% travel to global sites and suppliers.

Working Conditions:

2-year fixed-term contract with remote work; presence at offices may be required based on legal and project needs.

Join us to make a difference in healthcare and advance your career in a challenging, rewarding environment.