Supplier Quality Engineer - Allure Consultant

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