Hybrid Senior Supplier Quality Engineer NPI & PPAP

Lancesoft; Fort Worth (TX); Hybrid; USD 85,000 - 115,000; Full time

Job summary

Lancesoft in Fort Worth, TX is seeking a skilled professional to ensure suppliers deliver quality parts, materials, and services. You will collaborate with cross-functional teams on NPI projects and supplier qualification activities, including PPAP deliverables and inspection methods.

Responsibilities include maintaining the approved supplier list, qualifying suppliers to standards, managing change orders, and disposition of non-conforming material.

Qualifications

• Requires a University Degree and a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience.
• Experience with PPAP and related deliverables such as control plans, PFMEA, IQ/OQ/PQ documents, process capability studies and first article inspections.
• Experience with medical device quality system requirements.

Responsibilities

• Add and maintain supplier information on the ASL including supplier type, segmentation, selection, agreements, and audit records.
• Qualify suppliers according to company standards, including PPAP.
• Work with suppliers on qualification deliverables such as control plans, risk management files/PFMEA, IQ/OQ/PQ documents, process capability studies, and first article inspections.
• Prepare, review, and approve change orders.
• Investigate and disposition non-conforming material.
• Resolve supplier-related problems as they occur.
• Evaluate suppliers'internal functions to assess their overall performance and provide feedback in assessment of their operation.

Skills

PPAP

Control plans

PFMEA

IQ/OQ/PQ

Process capability

First article inspections

Supplier collaboration

Acceptance sampling

Inspection methods

Medical device QMS

Education

University degree

Advanced degree (preferred)

Job description

Lancesoft in Fort Worth, TX is seeking a skilled professional to ensure suppliers deliver quality parts, materials, and services. You will collaborate with cross-functional teams on NPI projects and supplier qualification activities, including PPAP deliverables and inspection methods.

Responsibilities include maintaining the approved supplier list, qualifying suppliers to standards, managing change orders, and disposition of non-conforming material.