Company:
Futran Tech Solutions Pvt. Ltd.
Location: Temecula
Closing Date: 29/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Title - Quality Engineer
Location - Temecula, CA(Onsite)
Roles & Responsibilities:
Location - Temecula, CA(Onsite)
Roles & Responsibilities:
- Identify internal requirements and external laws, regulations, guidance and standards (LRGS) applicable to one or more of division's quality systems
- Ensure internal activities and external partnership activities meet applicable regulations and quality standards including
- FDA QSR and ISO 9001/ ISO 13485
- Ensure external partnership activities meet applicable regulations and quality standards including FDA QSR and ISO 9001/
- ISO 13485
- Interpret applicable internal requirements and external LRGS and incorporate into requirements for use in business
- processes internally or with external partners
- Maintain and communicate monthly metrics
- Review and approval of product design changes and Quality System documentation
- Maintain external partner files
- Create Quality System and/or external partnership related documents
- Review external partnership assessment forms and assist in execution of onboarding and maintenance activities
- Participate in external inspection/audit activities
- Perform other duties as assigned by Management
- Bachelor's Degree in Life Sciences, Physical Sciences, Engineering discipline or equivalent technical
- Minimum 0-2+ years Quality Assurance experience
- Minimum 0-2+ years Medical Device manufacturing or pharmaceutical industries
- Working Knowledge of applicable regulations and standards such as, FDA QSR and ISO 13485
Share this job
Futran Tech Solutions Pvt. Ltd.