Dear Job Seeker,
I hope you're doing well.
My name is Abida Khan, Technical Recruiter at Intellectt Inc. I am reaching out regarding an exciting opportunity for a Supplier Quality Engineer position with one of our prestigious Medical Device clients
We are seeking professionals with experience in Supplier Quality Engineering, FDA Remediation, CAPA, Root Cause Analysis, DFMEA/PFMEA, Supplier Controls, Risk Management, and Medical Device Quality Systems.
I would love to connect and discuss this opportunity in more detail. If you are interested, please share your updated resume at abida.khan@intellectt.com.
I look forward to hearing from you
Job Title: Supplier Quality Engineer
Locations: Massachusetts
Job Summary
We are seeking an experienced Supplier Quality Engineer to support FDA remediation activities within a leading Medical Device organization. The ideal candidate will have strong experience in supplier quality, CAPA investigations, risk management, FMEA, supplier controls, and FDA compliance.
Core Responsibilities
• Assess supplier risk and implement supplier quality improvements.
• Review and align DFMEA, PFMEA, and supplier manufacturing processes.
• Support FDA remediation and Warning Letter activities.
• Conduct supplier quality investigations and CAPA activities.
• Support IQ/OQ/PQ validation activities.
• Collaborate with suppliers to improve process capability and quality controls.
Required Qualifications
• 5+ years of Supplier Quality Engineering experience.
• Medical Device industry experience.
• FDA remediation or Warning Letter remediation experience.
• CAPA, Root Cause Analysis, FMEA, and Supplier Quality experience.