Senior Medical Device Quality Engineer — Manufacturing

React Health; Bothell (WA); Sur place; USD 120 000 - 150 000; Plein temps

Avantages offerts par ce poste

Health insurance

401(k) with company match

Résumé du poste

React Health in Bothell, WA seeks a Senior Manufacturing Quality Engineer to lead process risk management for manufacturing transfer and daily production demand, and to identify and support continuous improvement opportunities.

The role requires strong experience with medical device quality systems, ISO standards, and cross-functional collaboration to ensure product quality from design through production.

Qualifications

• 7+ years in medical device manufacturing with regulatory standards (ISO14971, 21CFR820, ISO13485, IEC62304, IEC60601).
• Bachelor’s degree in engineering or life science required; Master’s preferred.
• Experience with transfer, validation and sustaining mechanical/software devices.
• Experience with process risk management creation and maintenance.
• Experience with test method development and validation.
• Experience with inspection plan development.
• Strong technical ability using computation tools and electronic QMS.
• Ability to learn new applications and tools quickly.
• Strong work ethic in a fast-paced environment; ability to mentor others.

Responsabilités

• Lead metrology, process mapping, pFMEA, control planning and validation.
• Review and approve changes to products with respect to risk management.
• Apply statistics to support business decisions.
• Conduct failure investigations and root-cause analysis.
• Improve lower maturity processes to ensure business continuity.
• Coordinate with engineering, logistics, finance and program management to define requirements.
• Attend meetings and training to maintain professional competence.
• Ensure department compliance with guidelines.
• Provide customer-focused interactions.

Connaissances

Quality engineering

Process mapping

Risk management

Statistical analysis

Regulatory knowledge

Mentorship

Cross-functional collaboration

Formation

Bachelor's degree in engineering or life science

Master’s degree in engineering or life science

Outils

QMS software

MS Office

CAPA system

Description du poste

React Health in Bothell, WA seeks a Senior Manufacturing Quality Engineer to lead process risk management for manufacturing transfer and daily production demand, and to identify and support continuous improvement opportunities.

The role requires strong experience with medical device quality systems, ISO standards, and cross-functional collaboration to ensure product quality from design through production.