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 nontechnical 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 problemsolving 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
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