Quality Engineer (Disposables) at Outset Medical

Outset Medical is seeking a Quality Engineer to join their team in Tijuana, Mexico. The Quality Engineer will focus on process validation strategies, non-conformances, MRB, CAPA’s, tracking and reporting on a monthly basis, and compiling and presenting data for management review, execution, and approvals of change orders.

The Quality Engineer will contribute to manufacturing process sustaining within a cleanroom environment, sterilization concepts and product release, contractor management (such as external laboratories and sterilization sites), and quality inspector management. The role will also support NPI’s activities from the SJ Facility to the MX facility by developing and executing the transfer validation strategy.

Outset Medical offers a collaborative and innovative environment where employees are valued and have the opportunity to make a significant impact on the lives of dialysis patients. They offer opportunities to build skill and expertise in a fulfilling career.

• Manufacturing process sustaining (Cleanroom environment).
• Sterilization concepts and product release.
• Contractor´s management, such as external laboratories and sterilization sites.
• Quality Inspectors management.
• Supporting NPI’s activities from SJ Facility to MX facility.

Requirements:

• Bachelor's degree in engineering or technical field or equivalent experience.
• Minimum of 3-5 years of experience.
• Knowledge of medical device regulations and standards such as 21 CFR 820, GMP, EN ISO 13485, and ISO 14971.
• Able to read and understand technical data.
• Competent using Microsoft Office suites.
• Strong written and verbal communication in English.

Outset Medical offers:

• A collaborative and innovative work environment.
• Opportunities for professional growth and development.
• A chance to make a meaningful impact on the lives of dialysis patients.