What are the responsibilities and job description for the Supplier Quality Engineer position at Shoolin Inc?
We are hiring a Supplier Quality Engineer (SQE) for an exciting contract opportunity supporting an FDA remediation project.
Location:- Marlborough, MA
Duration: 6 months contract with possible extension
We are looking for an experienced Supplier Quality Engineer to support critical FDA Warning Letter remediation activities within a regulated environment. This role requires strong expertise in supplier quality, risk assessment, and compliance, along with hands-on involvement in remediation initiatives.
Key Responsibilities:
- Support ongoing FDA Warning Letter remediation activities
- Classify supplier risks based on severity, occurrence, and detection criteria
- Strengthen supplier controls for medium to high-risk failure modes
- Review and align DFMEAs, PFMEAs, and supplier manufacturing processes
- Identify gaps from legacy systems post-acquisitions and recommend risk adjustments
- Evaluate supplier process capability and inspection methods
- Support and execute IQ, OQ, and PQ validation activities
- Troubleshoot supplier nonconformances and drive corrective actions
- Act as a technical liaison between internal teams and suppliers
Required Experience:
- Strong experience with FDA inspections and/or Warning Letter remediation
- Hands-on experience with CAPA investigations and root cause analysis