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Quality Assurance Engineer III (QMS)
Ref No.: 18-11744
Location: San Diego, California
Position Type:Contract
Summary
Responsible for quality engineering activities that address product/process changes, product/process quality issues, and compliance issues. This person may be involved in the development of new products and as such would support design control activities.

Tasks and responsibilities:

• Participate on design transfer, design control and improvement project teams.
• Review/audit records, testing plans, risk analysis.
• Conduct Quality training as applicable.
• Perform root cause analysis of product quality issues. Apply appropriate tools (e.g. statistics, fault tree analysis, etc.). Work with peers to develop corrective actions.
• Perform failure mode analysis on new or existing products. Working with peers, develop mitigations for failure modes, and verify the effectiveness of these mitigations.
• For both new products/processes and changes to existing products/processes develop verification and validation plans that assess if requirements are met. Oversee the execution of verification and validation plans. Write reports that summarize the verification and validation results.
• Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations.
• Support the NC and CAPA processes by performing investigations and root cause analysis, determining action plans and driving the actions to closure.
• Carries out duties in compliance with established business policies.
• Demonstrates commitment to the development, implementation and effectiveness of Alere Quality Management System per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
• Perform other duties & projects as assigned.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.


• Preferred educational background:
• BS degree or equivalent. An engineering or science background is preferred. Master's degree preferred.

• Preferred experiential background:
• Minimum of five to seven years related experience in quality or engineering (medical device / diagnostics preferred). Minimum of three years' experience with a Master's degree
• Experience with root cause analysis, failure mode analysis, verification, and validation
• Statistical tools including basic statistical inference, graphical methods, regression
• ASQ (ie – CQE, CMQ/OE, etc...) and/or six sigma certification preferred
• Core Competencies:
o Analytical/Problem Solving Skills (e.g. statistical, risk analysis, engineering analysis)
o Writing and Communication Skills (e.g. write technical reports, present data analysis)
o Interpersonal Skills
o Service Orientation
o Working knowledge of FDA regulations