Senior Medical Device Quality Engineer, Process Excellence

React Health Holdings, LLC; Bothell (WA); On-site; USD 110,000 - 150,000; Full time

Job summary

React Health in Bothell, WA is seeking a Senior Manufacturing Quality Engineer to lead process risk management for manufacturing transfers and daily production. You will identify improvements and ensure compliance with ISO14971, 21 CFR 820, ISO13485, and IEC standards while collaborating with cross-functional teams.

The role emphasizes hands-on quality engineering in a fast-paced medical device environment, with responsibilities spanning metrology, validation, CAPA, and change control, and

Qualifications

• 7+ years of experience in Medical Device manufacturing and ISO standards.
• Bachelor’s degree in engineering or life science.
• Experience with manufacturing transfer, process validation and sustaining of devices (mechanical and software driven).
• Experience with process risk management creation and maintenance.
• Experience with test method development and validation.
• Experience with inspection plans development.
• Strong technical ability using computational tools and electronic QMS.
• Ability to quickly learn new applications, tools, and concepts.
• Strong work ethic in a fast-paced environment.
• Ability to mentor others in quality principles.

Responsibilities

• Metrology, process mapping, pFMEA, control planning, test method validation, validation, process improvements, CAPA, NC, and change management.
• Review and approve changes to products with respect to process risk management.
• Apply statistics to make business decisions.
• Conduct failure investigation and root cause analysis.
• Support lower maturity processes with critical thinking for business continuity.
• Coordinate with engineering, logistics, finance, and program management to define system specs.
• Attend and participate in departmental meetings and trainings.
• Ensure compliance with department guidelines and policies.
• Provide customer-focused interactions.

Skills

ISO standards

Mfg transfer

Process validation

Risk management

Test method validation

Inspection plans

QMS tools

Statistics

Mentorship

Education

Bachelor’s degree in engineering or life science

Master’s degree in engineering or life science

Tools

DMAIC

Lean

Job description

React Health in Bothell, WA is seeking a Senior Manufacturing Quality Engineer to lead process risk management for manufacturing transfers and daily production. You will identify improvements and ensure compliance with ISO14971, 21 CFR 820, ISO13485, and IEC standards while collaborating with cross-functional teams.

The role emphasizes hands-on quality engineering in a fast-paced medical device environment, with responsibilities spanning metrology, validation, CAPA, and change control, and