Supplier Quality Engineer

Key Responsibilities

• Support and maintain the Supplier Quality Program in compliance with applicable regulatory requirements.
• Perform supplier evaluations, including risk assessments, questionnaires, and supplier audits as needed.
• Issue supplier quality complaints and drive corrective and preventive actions to resolution.
• Develop, review, and maintain Supplier Quality Agreements.
• Assess supplier and vendor changes, coordinate cross-functional reviews, and track implementation.
• Participate in internal quality audits and monitor corrective action effectiveness.
• Support regulatory inspections and customer audits.
• Maintain supplier quality documentation, including electronic filing and document management.
• Execute assigned quality projects within established timelines.
• Promote a safe, compliant, and quality-focused work environment.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or a related technical field (or equivalent experience).
• 3+ years of Supplier Quality or Quality Assurance experience within pharmaceutical, biotech, medical device, or other regulated manufacturing environments.
• Strong understanding of cGMP regulations and quality systems.
• Experience with:
  • Supplier Quality Management
  • Quality Agreements
  • Change Control
  • CAPA
  • Internal Audits
  • Deviations
  • Complaint Investigations
  • Document Control
• Experience using statistical tools for quality analysis.
• Proficiency with Microsoft Office.
• Strong analytical, problem-solving, organizational, and communication skills.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.
• Experience working cross-functionally with suppliers and internal stakeholders.