Manufacturing Quality Engineer

Bothell, WA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Job Description:

In this role youll ensure manufacturing processes meet quality and regulatory standards while driving improvements across production and compliance.
This is a hands-on role with strong cross-functional collaboration and an emphasis on risk management validation and problem-solving.

Responsibilities:

Support metrology process mapping pFMEA control planning validations CAPA NC and change management.
Assist in reviewing and implementing changes to commercialized products.
Conduct failure investigations and root cause analysis.
Apply statistics and data analysis to support key decisions.
Partner with engineering logistics quality and program management to meet system requirements.
Ensure compliance with ISO FDA and company quality standards.

Requirements:

3 5 years in medical device manufacturing (ISOCFR820 ISO13485 IEC62304 IEC60601).
Bachelors in engineering or Life Sciences (Masters preferred).
Background in manufacturing transfer process validation and sustaining mechanical/software-driven devices.
Experience with risk management activities inspection planning and test method validation.
Technical skills in computational tools & electronic QMS.
Strong communicator fast learner thrives in dynamic environments.
Six Sigma (DMAIC) or Lean training/experience.
Excellent collaboration & communication skills.

Job Description: In this role youll ensure manufacturing processes meet quality and regulatory standards while driving improvements across production and compliance. This is a hands-on role with strong cross-functional collaboration and an emphasis on risk management validation and problem-solving....