Sterility Assurance Engineer II (Tijuana)

Sterility Assurance Engineer II (Tijuana)

15 oct
|
Merit Medical Systems
|
Tijuana

15 oct

Merit Medical Systems

Tijuana

Work Shift:
DAYWork Schedule:

Why Merit?

At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.
ESSENTIAL FUNCTIONS PERFORMED

• Writes sterilization validation protocols and final reports.
• Coordinates and executes sterilization validations, including annual requalification’s and dose audits as necessary.
• Monitors the environmental monitoring program for the cleanrooms.
• Performs and documents product adoptions into existing EO sterilization cycles using the appropriate standards.
• Communicates and interfaces with contract sterilizers and laboratories.
• Works independently on standard projects while assistance is furnished on unusual problems.
• Receives guidance on specific assignment objectives, complex features, and possible solutions.
• May supervise the work of technicians in the team.




• Completes investigation and disposition of complex NC’s as applicable.
• Manages compliance to Sterility Assurance and Environmental metrics including NC timeliness.
• Works on special projects, writes ECN's, and leads continuous improvement activity.
• Oversees Environmental Monitoring programs for cleanrooms.
• Supports both internal and external audits.
• Performs other duties and tasks as required.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

• Lifting -- up to 50 lbs. – local practice may apply.
• Writing
• Sitting
• Standing
• Bending
• Vision
• Color perception
• Depth perception
• Reading
• Field of vision/peripheral

SUMMARY OF MINIMUM QUALIFICATIONS

• Education and/or experience equivalent to a Bachelor’s Degree in Engineering or technical field related to the department of assignment or industry with five years previous related experience.
• Ability to apply analytical skills and scientific technical principles in problem sol

📌 Sterility Assurance Engineer II (Tijuana)
🏢 Merit Medical Systems
📍 Tijuana

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