Location: Palo Alto, CA
Desired Start Date: ASAP
Duration: 1 year
Ensures use of efficient processes, test methods and appropriate sampling plans to provide assurance that quality parts and materials are delivered to the production floor. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
Support activities associated with Incoming Inspection within a medical device environment. Collaborates with Purchasing, Quality, Manufacturing, Engineering, and Regulatory for compliance to specifications, or quality/regulatory standards. Develops, applies, and maintains quality/regulatory standards and procedures in accordance with FDA 21 QSR 820 within the supplier quality team. Collaborates with new & existing product development teams to ensure quality standards are met. Works on assignments requiring considerable judgment and initiative. Understands implications or work and makes recommendations for solutions
Potentially owns and/or provides assistance in:
· Develops Inspection test methods
· Continuous improvement projects
· Equipment and test fixture, selection qualification and calibration
· Sets up and automates inspection methods and develops procedures.
· Works on projects to improve processes and efficiencies.
· Statistics; Sampling plans, Statistical Process Controls, Data Analysis, Process capabilities, Gauge R&R and other methodologies.
· Bachelor’s degree (or equivalent experience) and 3 years of related experience or Master’s Degree with 1 year of related experience.
· Certified Quality Engineer preferred
· Experience with Printed Circuit Boards and Cable Harness assembly, test, and fabrication.
· Experience with the creation of Procedures, Protocols, Test Reports, and Work Instructions.
· Knowledge and experience with Geometric Dimensioning and Tolerance (GD&T).
· Experience with touch probe CMM’s or multi-mode measurement systems such as OGP systems
· Ability to work independently and manage priorities and workflow in a rapidly changing environment.
· Familiarity with SAP or equivalent Enterprise Resource Planning systems.
· Excellent organizational, problem-solving, and analytical skills.
· Experience working in a cross-functional team environment.
· Excellent verbal & written communication skills.
· Good interpersonal skills.
-SAP is helpful, but not required
-Excel needed for Pivot tables
-Validation- IQ, OQ, PQ
- Create / Update procedures
- Calibration Review
-Participate on Incoming Inspection enhancement projects
APN Software Services INC
39899 Balentine Drive, Suite 385, Newark, CA 94560