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.
Responsibilities
- 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.
Supplier Quality Engineering
- 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.
Quality Systems & Compliance
- 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.
Required Qualifications
- 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
Preferred Qualifications
- 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