Engineer - Supplier Quality (Mid Level)

TechDigital Group; Florida; On-site; USD 90,000 - 125,000; Full time

Job summary

TechDigital Group seeks a Supplier Quality Engineer to elevate product quality for patients and customers while ensuring regulatory compliance and optimized cost of quality. You will drive supplier performance, participate in PQP implementation, and lead CAPA execution across assigned suppliers.

Responsibilities include supplier selection through robust qualification, audits, and ensuring adherence to CAPA processes within the QMS framework.

Qualifications

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

Responsibilities

• Improve supplier quality performance for assigned suppliers via Part Quality Plan (PQP) implementation and PQP submissions and approvals.
• Approve supplier selection through robust qualification processes, including supplier audits.
• Assure supplier compliance to Quality Management System (QMS) and regulatory requirements.
• Ensure CAPA plans are developed and executed at assigned suppliers in compliance with CAPA process.

Skills

Problem solving

Root cause analysis

Leadership / influence

Education

Bachelor’s Degree in engineering or technical discipline

7 years in manufacturing, engineering or quality assurance (alternative to degree)

Job description

The Supplier Quality Engineer is responsible for driving exceptional product quality for the patient, customer value beyond expectations, regulatory assurance and optimized Cost of Quality.

Responsibilities

1. Improve supplier quality performance for assigned suppliers via Part Quality Plan (PQP) implementation. Communicate, clarify and facilitate supplier Part Quality Plan (PQP) submissions, as well as conduct PQP review and approval for purchased products.
2. Approve supplier selection through robust qualification processes, including supplier audits.
3. Assure supplier compliance to Quality Management System (QMS) and regulatory requirements.
4. Assure Corrective and Preventive Action (CAPA) plans are developed and executed at assigned suppliers in compliance with CAPA process.

Qualifications and Requirements

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

Desired Characteristics

• ASQ Certified Quality Engineer or CQA Certified Quality Auditor.
• Demonstrated knowledge of Quality Management System tools and continuous improvement methodologies.
• Demonstrated supply quality experience within the medical device industry.