Supplier Quality Engineering

Join to apply for the Supplier Quality Engineering role at Katalyst CRO

Location:

Pittsburgh, PA. Salary: $50,000.00-$65,000.00

• Leading supplier qualification activities for new components and processes.
• Planning, executing, and documenting IQ/OQ/PQ and component/process qualifications.
• Reviewing supplier documentation such as FAIs, pFMEAs, Control Plans, Process Flow Diagrams.
• Evaluating process capability (Cpk) and performing statistical analysis.
• Partnering closely with Mechanical/Electrical R&D teams ბევრი alignment with design intent.
• Acting as the quality interface between R&D and selected suppliers.

• Bachelor's degree in engineering or a related technical field.
• 47 years of quality experience in a regulated industry (medical devices strongly preferred).
• Hands‑on knowledge of IQ/OQ/PQ, FMEAs, Control Plans, Cpk, Gage R&R, MSAs, FAIs.
• Ability to interpret engineering drawings and technical specifications.
• Strong communication skills, especially in supplier‑facing environments.

• Experience with injection molding, PCB manufacturing/assembly, machining, or casting.
• Familiarity with ISO 13485 or ISO 9001.

• Mid‑Senior level

• Contract

• Quality Assurance
• Industries:
  Pharmaceutical Manufacturing

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