Sr Supplier Qual Engineer - Exempt

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

Join our team in Fort Worth, TX, a vibrant city known for its rich cultural heritage and dynamic economy. We are seeking a skilled professional to ensure that suppliers deliver quality parts, materials, and services. This role is pivotal in collaborating with cross-functional teams on new product introduction (NPI) projects and parts.

Top 3 Technical Skills Required for the Role: PPAP part qualification including deliverables such as control plans, PFMEA, IQ/OQ/PQ documents, process capability studies, and first article inspections. Working with supplier and incoming inspection/metrology teams to develop inspection methods, validate test methods, and establish acceptance sampling plans. Experience with medical device quality system requirements;experience following specific quality systems preferred.

Education and Experience Required: 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.

Work Schedule: This is a full-time position requiring 40 hours per week. Onsite work is highly preferred, with a schedule of 4 days per week in the office and 1 day per week remote. Exceptional remote candidates may be considered.

Responsibilities: Add and maintain supplier information on the ASL (approved supplier list) including supplier type, segmentation, selection, agreements, and audit records. Qualify suppliers according to company standards, including PPAP (production part approval process). 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.

Career Stream and Differentiating Factors: This position is typically an individual contributor role with responsibility in a professional discipline or specialty. The role involves managing projects assigned and working with other stakeholders to achieve desired results. The majority of time is spent delivering and overseeing projects from design to implementation while adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

Required Knowledge and Experience: The role requires advanced knowledge of the job area combining breadth and depth, typically obtained through advanced education combined with experience. Practical knowledge of project management is beneficial.