Supplier Quality Engineer
Collabera Inc.
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