KH
Supplier Quality Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
3 months ago
- SPC
- Risk Management
- CAPA
3 months ago
- 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).
- 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.).
Supplier Quality Engineer · Katalyst Healthcares & Life Sciences