Senior Supplier Quality Engineer

Job Title: Senior Supplier Quality Engineer – Injection Molding

About the Role:

The Senior Supplier Quality Engineer - Injection Molding plays a pivotal role in identifying, leading, and executing large-scale complex projects related to injection molding. This position is recognized as a subject matter expert in the management and auditing of injection molding and resin suppliers.

This role drives forward improvement, ensuring the highest quality standards while embracing Convatec's core mission, values, and priorities. The job holder will lead efforts to identify, prioritize, and implement strategic initiatives that enhance supplier performance, foster collaborative relationships, and drive business growth.

Your Key Responsibilities:

• Provides leadership as a subject matter expert in Injection Molding, Statistical Sampling, Quality Sampling, CTQ Characterization, Risk Management activities, mold maintenance, and statistical process controls at supplier sites.
• Lead and provide input into global quality standards and policies regarding supplier quality performance and supplier selection process, ensuring compliance to 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.
• Drive significant change requests through to closure for our CCR process.
• Collaborate with R&D on improving CTQ requirements for the current product portfolio and NPD projects relating to injection molding.
• Support maintaining and develops 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.
• Manage complex supplier manufacturing Investigations relating to suppliers' issues through the SCAR and CAPA process.
• Demonstrate 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.
• Coach, review, and appropriately delegate work with lower-level professionals.
• Demonstrate 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 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.

Key Skills and Qualifications:

• 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 ISO13845 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.

Education and Certifications:

• 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.