Supplier Quality Engineer I

Key Responsibilities

Supplier Qualification & Management

• Support supplier selection, evaluation, and qualification activities (e.g., audits, capability assessments).
• Assist in onboarding new suppliers, including quality agreements and documentation review.
• Maintain Approved Supplier List (ASL) and related supplier records.
• Monitor supplier performance using metrics (defects, on-time delivery, responsiveness).

Supplier Quality Assurance

• Review and approve supplier-related documentation including: First Article Inspection (FAI), PPAP (Production Part Approval Process), if applicable, Certificates of Conformance (CoC) and material certifications.
• Ensure suppliers comply with regulatory requirements (FDA 21 CFR Part 820, ISO 13485, ISO 14971 as applicable).

Incoming Quality & Nonconformance Management

• Support incoming inspection processes and sampling plans.
• Investigate supplier-related nonconformances and defects.
• Initiate and manage Supplier Corrective Action Requests (SCARs).
• Verify effectiveness of corrective and preventive actions (CAPA support).

Auditing & Compliance

• Participate in supplier audits (on-site, remote, or desk audits).
• Ensure suppliers adhere to Good Manufacturing Practices (GMP) and internal procedures.
• Support internal and external audits (FDA, notified bodies, customers).

Risk Management

• Contribute to supplier risk assessments (criticality, risk ranking).
• Support risk mitigation strategies for high-risk suppliers or materials.

Continuous Improvement

• Drive supplier quality improvement initiatives.
• Analyze trend data and identify opportunities for defect reduction and process improvements.

Cross-Functional Collaboration

• Work closely with Purchasing, R&D, Manufacturing, and Regulatory teams.
• Support product transfers, validations, and design changes involving suppliers.

Qualifications

• Bachelor's degree in Engineering or related scientific/technical discipline.
• 0-3 years of experience in supplier quality, quality engineering, or manufacturing engineering in a regulated industry (medical device preferred).

Required Skills & Knowledge

• Strong working knowledge of: FDA 21 CFR Part 820, ISO 13485 quality systems, Risk management (ISO 14971).
• Expertise in root cause analysis and structured problem-solving methodologies.
• Experience with CAPA systems and regulatory compliance expectations.
• Hands-on experience with supplier audits and performance management.
• Knowledge of validation methodologies (IQ/OQ/PQ) and statistical tools (SPC preferred).
• Ability to interpret engineering drawings, specifications, and technical documentation.
• Strong analytical, communication, and decision-making skills.

Preferred Qualifications

• ASQ Certified Quality Engineer (CQE) or equivalent certification.
• Lead Auditor certification (ISO 13485).