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Validation Engineer II (QMS)
Ref No.: 18-10942
Location: San Diego, California
Title - Validation Engineer II (QMS)
Location  - San Diego CA
Duration - 14+ Months 


Validation authors for automation assembly equipment


Summary:

This position is responsible for ensuring validations are addressed according to the QMS, Validation Plan, GMP, ISO and current applicable regulations and guidelines Provides support for process validation including new product development and legacy product manufacturing.

Tasks and responsibilities:
• Provide technical expertise and guidance for the preparation and execution of validation protocols and reports.
• Review and troubleshoot anomalies, deviations, etc.
• Resolves and consults on applicable validation compliance and manufacturing process issues.
• Mentor and leads projects.
• Provide technical reviews of protocols.
• Contribute at the validation project team level for validation activities.
• Assist in developing and providing technical training.
• May provide guidance to less senior staff.
• May work with hazardous materials.
• Carries out duties in compliance with established business policies.
• Demonstrates commitment to the development, implementation and effectiveness of 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 in engineering or related field.

Preferred experiential background:
• Minimum 3 years related experience.
• Exposure to validation of in-vitro diagnostic device and medical device manufacturing processes.
• Knowledge of analytical and physical test methods and their respective validations.
• Comprehensive knowledge of validation documentation.
• Knowledge of federal and other regulations governing medical device assembly and design, e.g. GMP, QSR, ISO and CMDR.
• Able to work with a variety of people on multiple projects.
• Demonstrate problem-solving and troubleshooting skills
• Strong verbal and written communication skills
• Organized and detail oriented
• Knowledge and ability to use MS Office and other manufacturing systems
• Ability to work in a team environment

Tools and Equipment Used: Various manual tools and semi-automated and automated pneumatic, mechanical and electrical equipment; computer and hazardous materials may be used. Possible exposure to Blood borne pathogens and chemicals.