JOb Role- Senior SQE Job Location-Pittsburgh, PA Job Description

Responsible for achieving a state of high-quality performance at our supplier partners through the application and practice of Advanced product quality planning "APQP" during industrialization of products/parts within the new product introduction "NPI" process.

Participate in supplier sourcing process.

Quality engineering capability assessment of potential new suppliers.

core member of project teams.

Drive APQP plan development, Execution, Monitoring and control as pert of the transfer process.

Contribute to supplier project book content.

Support Design for excellence "DFX" collaboration between R& and Supplier.

Ensure critical to quality characteristics are flown down to supplier.

Part submission warrant plans, Deliverables, Line release and completion.

Drive supplier quality improvement and development through APQP.

Strong technical/Documentation skills for regulated medical devices design environment, including requirement definition

Demonstrated ability to effectively work with cross-functional stakeholders to ensure the design meets their expectation and needs, and that requirements are properly documented.

Skills:

Process validation (IQ/OQ/PQ)

Risk management.

FMEA.

PFMEA

Knowledge of ISO 13485/9001/FDA

GD & T

Knowledge of Manufacturing Quality systems and working in a regulated industry

Statistical Methods/MSA/Acceptance sampling.

Supplier coordination

CTQ

CTS

FAI

APQP

PSW

Supplier Training

Molding

Plastic