Description:
Position Summary
The Quality Engineer I (QE I) supports manufacturing operations by helping ensure products and processes consistently meet quality, regulatory, and business requirements. This role works closely with Manufacturing, Engineering, Supply Chain, and other cross-functional partners to support day-to-day production, investigate quality issues, maintain compliance with the Quality System, and drive continuous improvement.
What You'll Do
- Provide Quality Engineering support for day-to-day manufacturing operations and production activities.
- Review manufacturing documentation and records to ensure compliance with approved procedures, specifications, and quality requirements.
- Support the identification, documentation, investigation, and resolution of manufacturing quality issues.
- Initiate and support Nonconforming Material Reports (NCMRs) and other quality records, including investigation and disposition activities.
- Participate in root cause investigations and support implementation of corrective and preventive actions.
- Support manufacturing process changes, validations, qualifications, and continuous improvement activities.
- Support audit and inspection readiness and assist with internal and external audit activities as needed.
- Ensure activities are performed in accordance with applicable procedures, Quality System requirements, and regulatory standards.
- Perform other Quality Engineering responsibilities as assigned.
Required Qualifications
- Bachelor's degree in Engineering, Science, or another related technical discipline, or an equivalent combination of education and relevant technical experience.
- 0-2 years of experience in Quality, Engineering, Manufacturing, Operations, or another related technical field.
- Demonstrated ability to analyze information, solve problems, and make sound decisions using available data.
- Strong written and verbal communication skills.
- Ability to work effectively in a cross-functional, team-based manufacturing environment.
- Strong attention to detail and organizational skills.
- Ability and willingness to learn manufacturing processes, quality systems, and regulatory requirements.
Preferred Qualifications
- Internship, co-op, academic, or professional experience in a manufacturing or regulated environment.
- Experience or coursework related to Quality Engineering, Manufacturing Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related discipline.
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