Staff Quality Engineer - New Product Introduction (Medical Devices)

Stryker Corporation; Irvine (CA); Presencial; USD 103 000 - 171 000; Tempo integral

Resumo da oferta

Stryker Corporation in Irvine, CA is seeking a Staff Quality Engineer to support the development, transfer, and introduction of new medical devices and manufacturing processes.

You will lead quality activities for design transfer, PFMEA, process validation, inspection strategy, and supplier quality, ensuring compliance with ISO 13485 and GMP.

The role emphasizes risk management, MSA, DMAIC, and right-first-time performance across launch initiatives, with up to 20% travel.

Qualificações

• Bachelor’s degree in Engineering or a related technical discipline is required.
• Experience in a regulated manufacturing environment is required.
• Experience with risk-based and statistical quality techniques (FMEA, sampling, capability, MSA).

Responsabilidades

• Lead quality engineering activities for new product and process introductions, ensuring design transfer deliverables are documented and aligned with quality and regulatory requirements.
• Evaluate manufacturing and process risks using PFMEA and support risk management activities per ISO 14971.
• Develop inspection strategies, sampling plans, First Article Inspection approaches, and MSA strategies.
• Develop and approve process validation strategies, protocols, reports, and data analyses for capable, scalable manufacturing.
• Apply statistical methods and structured problem-solving tools to process characterization, capability analysis, nonconformances, CAPA, and root-cause investigations.
• Support Design for Manufacturing by influencing process design, production specs, inspection optimization, tooling and human-error risk controls.
• Lead quality activities for supplier qualification, supplier validation, PPAP, supplier certification, and quality agreements.
• Represent Quality during design reviews and design transfer, tracking launch-quality measures including right-first-time performance, manufacturing loss, inspection cost, and product escapes.

Conhecimentos

Quality engineering

Risk management

FMEA

MSA

Process capability

Statistical methods

Root cause analysis

DMAIC

Design for Manufacturing

Supplier quality

Formação académica

BS in Engineering

Descrição da oferta de emprego

Stryker Corporation in Irvine, CA is seeking a Staff Quality Engineer to support the development, transfer, and introduction of new medical devices and manufacturing processes.

You will lead quality activities for design transfer, PFMEA, process validation, inspection strategy, and supplier quality, ensuring compliance with ISO 13485 and GMP.

The role emphasizes risk management, MSA, DMAIC, and right-first-time performance across launch initiatives, with up to 20% travel.