Quality Assurance Engineer III (QMS) / Technical Writer
Category: IT- Development
San Diego, California
Job Title: Technical Writer/QA Engineer
About the Opportunity: A global leader in diagnostics and medical device manufacturing is looking for a driven individual to join their Software Quality Engineering team. This is an opportunity to work with a well-respected team and assist in the delivery of business-critical software on a 1+ year contract. If you are looking for the next step in your career don’t hesitate to apply below!
- Participate on design transfer, design control, and improvement project teams to review/audit records, testing plans, and conduct risk analysis.
- Perform root cause analysis of product quality issues applying appropriate tools (e.g. statistics, fault tree analysis, etc.) and working 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 overseeing the execution of plans and writing reports that summarize the 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.
Requirements and Education
- Bachelors’ Degree in engineering or science and a minimum of 2 years of related experience.
- Experience in medical device industry in quality or engineering
- 2-5 years in quality assurance engineering experience in an FDA regulated environment is strongly preferred.
- Experience with root cause analysis, failure mode analysis, verification, and validation
- Statistical tools including basic statistical inference, graphical methods, regression
- ASQ (i.e. – CQE, CMQ/OE, etc.) and/or six sigma certification preferred
Interested in learning more? Please don’t hesitate to give us a call at 858-242-5676 or visit our website www.sayvasolutions.com for more information, or follow our LinkedIn page for updates here: https://www.linkedin.com/company/sayva-solutions. If you are already working with a Sayva team member, contact them directly and they will be happy to discuss this opportunity in more detail.
About Sayva: Sayva’s technology division provides consulting, contract to hire, and direct hire recruiting to support project and full-time placement needs. Our decades of combined industry experience has fostered a vast network and emphasis on efficiency, responsiveness, and quality results.