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Supplier Quality Engineer

Karwell Technologies

Newark, DE

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JOB DETAILS
SKILLS
Auditing, Code of Federal Regulations, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Decision Support, FDA Requirements, Failure Analysis, ISO (International Organization for Standardization), ISO 9001, Maintain Compliance, Manufacturing Engineering, Manufacturing/Industrial Processes, Medical Equipment, Metrology, Onboarding, Performance Analysis, Performance Metrics, Problem Solving Skills, Process Improvement, Process Validation, Production Part Approval Process (PPAP), Project/Program Management, Purchasing/Procurement, Quality Control, Quality Engineering, Regulations, Regulatory Compliance, Regulatory Requirements, Research & Development (R&D), Risk Management, Root Cause Analysis, Statistical Sampling, Statistics, Surveillance, Systems Analysis, Total Quality Management (TQM), Vendor/Supplier Evaluation, Vendor/Supplier Management, Vendor/Supplier Selection
LOCATION
Newark, DE
POSTED
9 days ago
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.
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).
Requirements:
  • 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.).

About the Company

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Karwell Technologies