Supplier Quality Engineer - Senior

Job Title : Supplier Quality Engineer
Location : Santa Clara, CA 95054
Job id : ABOJP00040093
Contract Duration : 12+ Months Contract with possibility to extend

• Process validation plan with Supplier
• Familiar with FDA Regulations
• Medical Devices Exp
• Manage supplier relationships
• Process validations for machine components and Injection comp
• Familiar Gage R&R.

Top 3 Skill

• Supplier Manage
• Test method Validation
• Process method validation

Key Responsibilities:

• 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 Client Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies, and inspection procedures.
• ssesses 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.
• pplies 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 Client supplier development quality program policies, procedures, and forms.

Qualifications:

• Bachelor's degree within an Engineering field or related science-based discipline.
• 5+ years of related work experience (Medial device preferred).
• Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization.
• bility to work in a highly matrixed and geographically diverse business environment.
• bility to work within a team and as an individual contributor in a fast-paced, changing environment.
• bility to leverage and/or engage others to accomplish projects.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail