Demo

Supplier Quality Engineer

ExtendMyTeam
Miami, FL Full Time
POSTED ON 4/3/2025
AVAILABLE BEFORE 5/18/2025

Our partner is looking for a Supplier Quality Engineer to join our Operations team to take the lead in managing our critical supplier relationships and ensuring the quality and compliance of all our products. In this pivotal role, you will serve as the primary quality interface between the company's and our supplier network, leading qualification processes, conducting risk assessments and audits, investigating quality issues, and driving continuous improvement initiatives—all while ensuring strict adherence to FDA regulations, ISO 13485 and international standards. The ideal candidate combines technical expertise with strong relationship management skills to maintain our high standards of product quality and safety.


Responsibilities to include:

  • Supplier Qualification & Management:
    • Lead the qualification process for new suppliers, conducting risk assessments, capability evaluations, and quality system audits.
    • Develop and maintain the Approved Supplier List (ASL) based on performance, compliance, and risk analysis.
    • Collaborate with procurement and R&D to ensure suppliers meet technical and regulatory requirements.
    • Establish and monitor supplier Key Performance Indicators (KPIs), such as defect rates and compliance metrics.
  • Supplier Audits & Compliance:
    • Plan, execute, and document supplier audits in compliance with FDA, ISO 13485, and internal quality requirements.
    • Ensure suppliers implement corrective and preventive actions (CAPAs) for any non-conformances identified during audits.
    • Maintain supplier audit schedules and track follow-up activities to ensure timely resolution of findings.
  • Supplier Issue Management & Continuous Improvement:
    • Investigate supplier-related quality issues, including non-conforming materials, component failures, and deviations.
    • Work closely with suppliers to implement process improvements, reduce defects, and enhance product reliability.
  • Regulatory Compliance & Documentation:
    • Ensure supplier documentation, such as Certificates of Compliance (CoC) and process validations, meet regulatory requirements.
    • Maintain supplier-related quality records in compliance with ISO 13485, and other relevant standards.
    • Support regulatory and customer audits by providing supplier-related quality documentation and evidence of compliance.
  • Cross-Functional Collaboration;
  • Partner with Operations, Engineering, and Procurement teams to resolve supplier-related manufacturing issues.
  • Participate in Design Review meetings to provide input on supplier capabilities and constraints.
  • Support complaint investigations related to supplier components and materials.

 

What You Will Need

  • Bachelor's degree in Engineering, Quality, or related technical field.
  • 4 years of experience in supplier quality within the medical device industry.
  • Thorough knowledge of FDA regulations, ISO 13485, and medical device quality systems.
  • Certified quality professional (CQE, CQA, or equivalent) preferred.
  • Experience with risk management methodologies (FMEA, FTA) and statistical process control.
  • A keen eye for detail and a results-driven approach
  • Strong auditing skills with demonstrated ability to identify and resolve quality issues.
  • Excellent verbal communication skills with ability to speak effectively with clients, vendors, management staff and employees of organization
  • Working knowledge of Microsoft Excel, Word, Access, Visio, and documentation control software (preferably Aras PLM), material management software, and statistical application software
  • Willingness to travel (approximately 20-30%) for supplier audits and assessments.

 

Who You Will Work With

Our partner is an organization that values collaboration and community. As the Supplier Quality Engineer, you will work closely with Operations, Engineering, and Procurement teams.

If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution. Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right. Surveys & Data Sets

What is the career path for a Supplier Quality Engineer?

Sign up to receive alerts about other jobs on the Supplier Quality Engineer career path by checking the boxes next to the positions that interest you.
Income Estimation: 
$83,806 - $99,902
Income Estimation: 
$101,442 - $121,314
Income Estimation: 
$130,439 - $161,324
Income Estimation: 
$172,572 - $208,062
Income Estimation: 
$83,806 - $99,902
Income Estimation: 
$101,442 - $121,314
Income Estimation: 
$68,970 - $84,869
Income Estimation: 
$83,806 - $99,902
Income Estimation: 
$101,442 - $121,314
Income Estimation: 
$122,860 - $148,594
View Core, Job Family, and Industry Job Skills and Competency Data for more than 15,000 Job Titles Skills Library

Job openings at ExtendMyTeam

ExtendMyTeam
Hired Organization Address Miami, FL Full Time
Our partner is looking for a Strategic Sourcing Manager to join our Operations team and lead the process of finding the ...
ExtendMyTeam
Hired Organization Address Miami, FL Full Time
How You Will Make an Impact Our partner is looking for a Sr. Manager of Quality Assurance to join our Operations team an...
ExtendMyTeam
Hired Organization Address New York, NY Full Time
Our client is looking for an HR Generalist to join the team. You will be responsible for managing all human resources fu...
ExtendMyTeam
Hired Organization Address Miami, FL Full Time
How You Will Make an Impact Our partner is seeking a highly skilled Customer Operations Manager to join their dynamic sa...

Not the job you're looking for? Here are some other Supplier Quality Engineer jobs in the Miami, FL area that may be a better fit.

Supplier Quality Engineer

Beckman Coulter Life Sciences, Miami, FL

Supplier Quality Engineer

Frida, Miami, FL

AI Assistant is available now!

Feel free to start your new journey!