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Sustaining Engineer - Supplier Quality
Employment Type:
Direct
Category: Manufacturing Engineer
Job Number: 10993
Pay Rate: $95k - $105k/yr
Job Description
Qualifications
- Bachelor’s degree in engineering or related field
- Minimum of 3 years of experience in a related role within a medical device or manufacturing environment
- Experience with root cause analysis and process validation (IQ, OQ, PQ)
- Strong understanding of supplier quality management and experience supporting supplier development and qualification
- Experience working in FDA-regulated environments and managing supplier capacity ramp-up
- Familiarity with statistical analysis, process monitoring, and implementing corrective actions
- Knowledge of design, process, or quality improvements in medical devices
Responsibilities
- Lead and support continuous improvement initiatives for products, processes, and suppliers, including change control execution.
- Perform root cause analysis and implement corrective actions for component failures and non-conformances, collaborating with suppliers and internal teams.
- Support supplier qualification, capacity scaling, and validation planning to meet production demand.
- Collaborate with Quality, Manufacturing, and Product Development to define inspection requirements, verify changes, and improve next-generation products.
- Manage internal and external communication related to sustaining projects and ensure compliance with FDA and QMS documentation standards.