Job Summary

The Supplier Quality Engineer is responsible for driving product quality, ensuring regulatory compliance, and optimizing the Cost of Quality for assigned suppliers. This role focuses on improving supplier performance through the implementation of Part Quality Plans (PQP), conducting supplier audits, and ensuring compliance with Quality Management System (QMS) and regulatory requirements.

Key Responsibilities

Improve supplier quality performance through PQP implementation.
Communicate, clarify, and facilitate PQP submissions, as well as conduct PQP review and approval for purchased products.
Approve supplier selection through qualification processes, including audits.
Ensure supplier compliance with QMS and regulatory requirements.
Develop and execute Corrective and Preventive Action (CAPA) plans in compliance with the CAPA process.

Required Qualifications

Bachelor’s Degree in engineering or a technical discipline (or non-technical degree with 7 years of experience in manufacturing, engineering, or quality assurance).
Minimum 5 years of experience in manufacturing, engineering design, quality assurance, or regulatory assurance.
Strong problem-solving and root cause analytical skills.
Ability to lead and influence others to drive change.

Preferred Qualifications

Knowledge of Quality Management System tools and continuous improvement methodologies.
Experience in supply quality within the medical device industry.

Certifications

ASQ Certified Quality Engineer or CQA Certified Quality Auditor

Location: New Port Richey, Florida,

Education: High School

Certification: ASQ Certified Quality Engineer , CQA Certified Quality Auditor

Skills: regulatory requirements,asq,analytical skills,supplier quality management,regulatory compliance,quality assurance,continuous improvement methodologies,quality management system (qms),corrective and preventive action (capa),compliance,continuous improvement,quality control,management,cost of quality,management system,conducting,manufacturing,problem-solving,root cause analysis

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Supplier Quality Engineer