Supplier Quality Engineer
Collabera Inc.
This job is no longer accepting applications
See open jobs at Collabera Inc..See open jobs similar to "Supplier Quality Engineer" AnitaB.org.Quality Assurance
Santa Clara, CA, USA
USD 49-54 / hour
Posted on Apr 22, 2025
Supplier Quality Engineer
Contract: Santa Clara, California, US
Salary Range: 49.00 - 54.00 | Per Hour
Job Code: 361215
End Date: 2025-05-21
Days Left: 28 days, 10 hours left
To discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL - www.linkedin.com/in/deepak-arya-8a79aa22a/), email your updated resume at Email - deepak.arya@collabera.com or give me a call at (425)-298-1474. Thank you!
Pay rate: 49 - $54/hr.
Industry: Medical Device
Duration: 12 months [+ Possibilities of extension]
Description:
- Performs and lead TMVs, DEOEs, IQs, OQs PQs as well as component Qualifications.
- Review specifications using basic Knowledge of SolidWorks and statistical software such as Minitab or JMP
- Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements.
- Performs re-assessment of suppliers each year per a defined schedule.
- Identifies supplier contacts and solicits required documents from suppliers.
- Tracks supplier responses and conducts follow-up and escalation as necessary.
- Conduct phone calls with supplier as needed to expedite responses or answer questions.
- Reviews current Quality Agreements and determines need to revise
- Solicits revised Quality Agreements as determined.
- Obtains and analyzes performance and quality indications information from internal sources for each supplier.
- Prepares and submits required quality records and documents for closure and filing.
- Reviews and approves all supplied product drawings and component quality plans.
- Manages the development of supplied product inspection procedures and first article requirements.
- Provides engineering guidance to Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies, and inspection procedures.
- Assesses supplier capabilities through direct visits, technical discussions directed testing and quality system audits.
- Proactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests, and technical discussions.
- Participates and provides engineering ownership for all supplied product Non-Conforming Material Reviews.
- Contributes and participates in supplier performance reviews
- Evaluates and develops Supplied Data Agreement, Skip Lot, Dock-to-Stock, CoC, and CoA partnerships with suppliers.
- Applies sound engineering analysis and judgment to reduce the need for inspection in accordance with program policies.
- Works with Manufacturing engineering to assess and address purchased product issues.
- Participate in or lead teams in supporting Supplier Development Quality program requirements (e.g., represent the Supplier Development Quality function as a Core Team Member).
- Mitigates risk by working with the Suppliers to document Process Flow Charts, PFMEAs, and Control Plans.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Contributes to the development, maintenance, and improvement of supplier development quality program policies, procedures, and forms.
Qualifications:
- Bachelor’s degree within an Engineering field or related science-based discipline with 5+ years of related work experience (Medial device preferred).
Job Requirement
- Quality Engineer
- ISO 13485
- CAPA
- IQ
- OQ
- PQ
Reach Out to a Recruiter
- Recruiter
- Phone
- Deepak Arya
- deepak.arya@collabera.com
Apply Now
Apply Now
This job is no longer accepting applications
See open jobs at Collabera Inc..See open jobs similar to "Supplier Quality Engineer" AnitaB.org.