Manufacturing Quality Engineer at Katalyst Healthcares Life Sciences
Bothell, WA 98012, USA -
Full Time


Start Date

Immediate

Expiry Date

18 Sep, 25

Salary

0.0

Posted On

20 Jun, 25

Experience

4 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Vocational Education, Root Cause, Technical Documentation, Data Analysis, Process Monitoring

Industry

Mechanical or Industrial Engineering

Description

Responsibilities:

  • Analyses defects and manage Non-Conformances (Company) and Quality Notifications (QNs).
  • Implement effective Corrective and Preventive Actions (CAPAs).
  • Support PFMEA assessments and design transfer activities.
  • Monitor operations performance, assist in risk assessments and continuous improvement.
  • Coordinate quality engineering tasks in support of New Product Introduction (NPI).
  • Utilize advanced statistical analysis for data trend interpretation.
  • Conduct process validation and support regulatory compliance efforts.
  • Collaborate with suppliers, R&D, and manufacturing teams to resolve quality issues.

Requirements:

  • Bachelor’s degree in mechanical engineering, Electronics Engineering, Science, or equivalent; Vocational Education accepted with additional experience.
  • None required with a bachelor’s degree.
  • OR 4+ years of experience with Vocational Education.
  • Process Quality Management.
  • Root Cause Analysis (RCA).
  • CAPA methodologies.
  • Regulatory knowledge.
  • Data analysis, DFQ, and technical documentation.
  • Risk assessments and process monitoring.
Responsibilities
  • Analyses defects and manage Non-Conformances (Company) and Quality Notifications (QNs).
  • Implement effective Corrective and Preventive Actions (CAPAs).
  • Support PFMEA assessments and design transfer activities.
  • Monitor operations performance, assist in risk assessments and continuous improvement.
  • Coordinate quality engineering tasks in support of New Product Introduction (NPI).
  • Utilize advanced statistical analysis for data trend interpretation.
  • Conduct process validation and support regulatory compliance efforts.
  • Collaborate with suppliers, R&D, and manufacturing teams to resolve quality issues
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