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
โข Assess supplier risk and implement supplier quality improvements.
โข Review and align DFMEA, PFMEA, and supplier manufacturing processes.
โข Support FDA remediation and Warning Letter activities.
โข Conduct supplier quality investigations and CAPA activities.
โข Support IQ/OQ/PQ validation activities.
โข Collaborate with suppliers to improve process capability and quality controls.
Required Qualifications
โข 5+ years of Supplier Quality Engineering experience.
โข Medical Device industry experience.
โข FDA remediation or Warning Letter remediation experience.
โข CAPA, Root Cause Analysis, FMEA, and Supplier Quality experience.