Sterility Assurance Engineer II – Medical Devices QA

Merit Medical Systems, Inc.; Tijuana; On-site; MXN 350,000 - 520,000; Full time

Benefits offered by this job

Medical Insurance

Onsite Clinic

Onsite Cafeterias

Vacation

Sick Time

Paid Holidays

401K

Health Savings Account

Job summary

Merit Medical Systems, Inc. in Baja California, Mexico seeks a professional to write sterilization validation protocols and reports, coordinate validations, and monitor environmental controls in cleanrooms.

You will interface with contract sterilizers and laboratories, supervise technicians, and drive continuous improvement. The role requires five years of related experience and a Bachelor's in engineering or a technical field, along with strong analytical and collaborative skills.

Qualifications

• Education and/or experience equivalent to a Bachelor’s Degree in Engineering or technical field with five years of related experience.
• Ability to apply analytical skills and scientific technical principles in problem solving and development.
• Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.
• Strong interpersonal and organizational skills and the ability to work effectively as a team member.
• Working knowledge of international standards as applicable to the department.
• Scientific techniques/evaluation/selection/application

Responsibilities

• 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.

Skills

Analytical skills

Team collaboration

Problem solving

Interpersonal skills

Education

Bachelor's Degree in Engineering or technical field

Tools

Spreadsheets

Word processing

Database software

Job description

Merit Medical Systems, Inc. in Baja California, Mexico seeks a professional to write sterilization validation protocols and reports, coordinate validations, and monitor environmental controls in cleanrooms.

You will interface with contract sterilizers and laboratories, supervise technicians, and drive continuous improvement. The role requires five years of related experience and a Bachelor's in engineering or a technical field, along with strong analytical and collaborative skills.