Quality EngineerMILLENNIUMSOFT • San Diego, CA, United States
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Quality Engineer
MILLENNIUMSOFT • San Diego, CA, United States
[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]
Roles & Responsibilities
- Perform equipment and process validation studies, including writing/reviewing protocols, reports, data analysis, and managing deviations.
- Ensure compliance with maintenance, preventive maintenance, calibration, and out-of-tolerance activities for medical devices or biological equipment.
- Author and execute installation, operational, and performance qualifications for analytical and manufacturing equipment.
- Execute validation and qualification of GMP equipment and functions within the manufacturing facility.
- Review and update FMEA or risk documents for validation activities.
- Support business continuity during manufacturing process relocation, including QA inspections, dual operation support, and document review for product release.
- 3-5 years of experience in the Medical Device, Biotech, or Pharma industry.
- 5-7 years of experience in the Medical Device, Biotech, or Pharma industry.
- Strong verbal and written communication, with proficiency in writing technical documents.
- Knowledge of quality systems (ISO 9001, ISO 14971, ISO 13485) and methodologies.
- Proficiency in process and equipment validation, risk management, and supplier management.
- Basic statistical analysis knowledge (e.g., Minitab, Excel).
- Hands-on experience with Six Sigma methodologies.
- Familiarity with SAP and equipment management systems (e.g., BMRAM).
- Ability to work both independently and in teams with minimal supervision.
- Strong organizational skills with the ability to multitask.
- Bachelor's degree in Biological Sciences, Chemistry, Biotech Engineering, Bioengineering, or a related field.
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