Supplier Quality Engineer

Katalyst CRO; Newark (DE); On-site; USD 110,000 - 160,000; Full time

Job summary

Katalyst CRO is seeking a Senior Supplier Quality Engineer to oversee supplier quality activities for components, materials, and services. You will ensure suppliers meet regulatory and business requirements and collaborate with R&D, Design Assurance, and manufacturing teams.

The role requires deep knowledge of medical device regulations, CAPA, PPAP, and statistical methods to prevent failures and improve processes. Extensive cross-functional interaction and effective documentation are essential.

Qualifications

• Bachelor's degree in Engineering or related field required.
• ISO 13485 Lead Auditor certification required.
• Strong knowledge of Medical Device Regulations (FDA CFR 820, ISO 13485, ISO 14971, ISO 9001).
• Experience with CAPA, IQ/OQ/PQ validations, GR&R, and SPC.

Responsibilities

• Provide oversight of supplier quality, ensuring materials and services meet regulatory and business requirements.
• Perform supplier technical reviews to assess capability to manufacture materials/components.
• Oversee supplier manufacturing processes, QC practices, corrective actions, and FAI.
• Define/approve PPAP requirements for new/revised parts.
• Collaborate with R&D and Design Assurance to ensure product quality and reliability.
• Manage supplier quality events (SCARs, SACAs, NCEs) with KPI tracking.
• Conduct root cause investigations and statistical analysis with suppliers.
• Coordinate cross-functional teams to resolve supplier-related issues.
• Maintain supplier quality records and generate performance reports.
• Onboard and implement new suppliers with qualified processes.
• Apply SPC, TQM, and statistical sampling to optimize processes.

Skills

Supplier quality

Regulatory compliance

Problem solving

Statistical analysis

Project management

Cross-functional teamwork

Documentation

Education

Bachelor's degree in Engineering

ISO 13485 Lead Auditor

Job description

• Provide support to the Supplier Quality organization dedicated to the oversight of components, materials, and services.
• Serve as a technical resource across the organization to ensure suppliers meet all quality, regulatory, and business requirements.
• Conduct technical reviews of suppliers to assess their capability to manufacture materials and components.
• Oversee, assess, and monitor supplier manufacturing processes, quality control practices, corrective actions, continuous improvement activities, and First Article Inspections (FAI).
• Define and approve PPAP (Production Part Approval Process) requirements for new and revised purchased parts.
• Collaborate with suppliers, Research & Development, and Design Assurance teams to ensure products meet fit, form, function, reliability, and quality requirements.
• Issue, manage, and follow up on supplier quality events including SCARs, SACAs, and NCEs while monitoring workflow compliance with established KPIs.
• Partner with suppliers to perform root cause investigations, problem solving, metrology assessments, and statistical analysis to prevent recurring failures.
• Work with Post Market Surveillance, Quality Engineering, Manufacturing Engineering, R&D, and other cross-functional teams to resolve supplier-related complaints and quality issues.
• Manage supplier-related nonconformities, containment actions, material disposition activities, and supplier sample returns as required.
• Maintain complete and accurate supplier quality records.
• Generate supplier performance metrics and reports to support stakeholder decision-making.
• Qualify, coordinate, and execute activities associated with onboarding and implementation of new suppliers.
• Utilize problem-solving tools such as SPC, TQM, and statistical sampling methodologies to optimize processes.
• Ensure compliance with Medical Device Regulations, cGMP, CFR 820, ISO 13485, ISO 14971, ISO 9001, and applicable global regulatory requirements.
• Support risk management activities, validation efforts (IQ, OQ, PQ), CAPA investigations, project management initiatives, and measurement system analysis (GR&R, AAA).

Job Summary

• Provide support to the Supplier Quality organization dedicated to the oversight of components, materials, and services.
• Serve as a technical resource across the organization to ensure suppliers meet all quality, regulatory, and business requirements.

Roles & Responsibilities

• Conduct technical reviews of suppliers to assess their capability to manufacture materials and components.
• Oversee, assess, and monitor supplier manufacturing processes, quality control practices, corrective actions, continuous improvement activities, and First Article Inspections (FAI).
• Define and approve PPAP (Production Part Approval Process) requirements for new and revised purchased parts.
• Collaborate with suppliers, Research & Development, and Design Assurance teams to ensure products meet fit, form, function, reliability, and quality requirements.
• Issue, manage, and follow up on supplier quality events including SCARs, SACAs, and NCEs while monitoring workflow compliance with established KPIs.
• Partner with suppliers to perform root cause investigations, problem solving, metrology assessments, and statistical analysis to prevent recurring failures.
• Work with Post Market Surveillance, Quality Engineering, Manufacturing Engineering, R&D, and other cross-functional teams to resolve supplier-related complaints and quality issues.
• Manage supplier-related nonconformities, containment actions, material disposition activities, and supplier sample returns as required.
• Maintain complete and accurate supplier quality records.
• Generate supplier performance metrics and reports to support stakeholder decision-making.
• Qualify, coordinate, and execute activities associated with onboarding and implementation of new suppliers.
• Utilize problem-solving tools such as SPC, TQM, and statistical sampling methodologies to optimize processes.
• Ensure compliance with Medical Device Regulations, cGMP, CFR 820, ISO 13485, ISO 14971, ISO 9001, and applicable global regulatory requirements.
• Support risk management activities, validation efforts (IQ, OQ, PQ), CAPA investigations, project management initiatives, and measurement system analysis (GR&R, AAA).

Education & Experience

• Bachelor's degree in an Engineering field from an accredited university.
• Minimum 8 years of professional experience.
• Medical Device industry experience required.
• ISO 13485 Lead Auditor certification required.
• Strong knowledge of Medical Device Regulations, cGMP, CFR 820, ISO 13485, ISO 14971, and ISO 9001.
• Experience with risk management, CAPA, IQ/OQ/PQ validations, measurement system analysis (GR&R, AAA), SPC, statistical sampling, and PPAP.
• Knowledge of project management techniques and global regulatory requirements (FDA, Canada, Brazil, Japan, etc.).