Quality Engineer I
About The Position
The Quality Engineer I supports the implementation and maintenance of FDA and ISO 13485:2016 compliant Quality Systems within an electro-mechanical medical device manufacturing environment, including Class 7/8 Cleanroom operations for manufacturing sterilized/disposable products. This role assists in managing the environmental monitoring system, including documenting alerts, supporting required responses and preparing trending data and reports for management. The Quality Engineer I also supports activities related to sterilization release records, investigations and resolution of non-conformances, environmental monitoring excursions, equipment calibrations and preventive maintenance, and action items associated with corrective actions.
Requirements
- Bachelor’s degree in engineering or a related field preferred, or equivalent combinations of education and experience.
- 1 -2 years of experience in medical device, biotech, or regulated industry.
- Ability to present verbal and written information, trends, and investigation results to cross-functional teams and management.
- Proficiency in Microsoft Word, Excel and Outlook, Visio, PowerPoint software applications.
- Capable of preparing technical reports, business correspondence, etc.
- Ability to understand engineering drawings, specifications, diagrams, schedules, and written instructions.
- Proven ability to plan, prioritize, and complete technical assignments with limited supervision.
- Able to perform varied tasks consistently and maintain clear communication across teams.
- A current US work authorization is required.
Nice To Haves
- Familiarity with statistical controls and data analysis tools is a plus.
Responsibilities
- Manage the QMS environmental monitoring system, including response and documentation of alert notifications (e.g., Vaisala).
- Provide quality engineering support and guidance for cleanroom environmental operations to ensure compliance with applicable requirements.
- Document, manage, and drive investigations and resolutions related to environmental monitoring excursions.
- Assist with equipment management activities, including calibration and preventive maintenance coordination.
- Prepare and report environmental excursion data and trending analyses to management to support process improvements.
- Collaborate with other departments as needed to assist with investigations and continuous improvement activities.
- Assist with documentation associated with product sterilization activities.
- Support additional Quality Assurance/Quality Control projects and tasks as assigned.
Benefits
- attractive benefits package
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
