Supplier Quality Engineer

Overview

We are seeking a motivated and detail-oriented Supplier Quality Engineer (Entry Level) to support quality engineering systems, methodologies, and compliance activities within a regulated manufacturing environment. This role plays a critical part in ensuring product quality, regulatory compliance, and continuous improvement while partnering cross-functionally to support operational excellence and new product development.

The Quality Engineer will serve as a key quality representative, supporting internal teams, suppliers, and stakeholders to strengthen quality systems and drive measurable improvements across manufacturing and supplier operations.

• Quality Engineering & Process Control:
  Develop, implement, and maintain effective process control systems to support product development, qualification, and ongoing manufacturing.
• Lead and support implementation of assurance activities, process controls, and CAPA systems to meet internal, customer, and regulatory requirements.
• Apply structured problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Support development and execution of streamlined business systems to proactively identify and resolve quality risks.
• Act as a quality leader and advocate across cross-functional teams to drive quality culture and best practices.

• Drive supplier quality performance through Part Quality Plan (PQP) implementation and ongoing supplier engagement.
• Review, approve, and facilitate supplier PQP submissions for purchased products.
• Lead supplier qualification and selection through robust audit and assessment processes.
• Ensure supplier compliance with Quality Management System (QMS) and regulatory requirements.
• Lead and monitor supplier CAPA development and execution to ensure sustained quality improvements.

• Build quality into all aspects of work by maintaining compliance with internal quality systems and external regulatory requirements.
• Support regulatory assurance, audit readiness, and continuous improvement initiatives.

• Bachelor’s Degree in Engineering or related technical discipline (OR non-technical degree with 5+ years of relevant manufacturing, engineering, or quality experience)
• Minimum 3 years of experience in manufacturing, engineering, quality assurance, or regulatory assurance
• Strong problem-solving and root cause analysis skills

• ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA)
• Demonstrated experience with Quality Management System (QMS) tools and continuous improvement methodologies
• Prior supplier quality experience within the medical device or regulated manufacturing industry