Sterility Assurance Engineer II

Merit Medical Systems, Inc.; Tijuana; On-site; MXN 600,000 - 900,000; Full time

Benefits offered by this job

Medical/Dental Insurance

Onsite Cafeterias

Paid Holidays

401K

Job summary

Merit Medical Systems, Inc. in Tijuana, MX, is seeking a Sterilization Validation Specialist to write sterilization validation protocols, coordinate validations, and monitor environmental monitoring programs for cleanrooms.

You will work with contract sterilizers and laboratories, lead continuous improvement projects, and may supervise technicians. A Bachelor’s Degree in Engineering or a related technical field with five years of experience is required.

Qualifications

• Education and experience equivalent to a Bachelor's in engineering or related field, with five years of relevant work.
• Ability to apply analytical skills and scientific principles to problem solving.
• Strong computer skills: spreadsheets, word processing, database software.
• Excellent teamwork and organization; comply with international standards.

Responsibilities

• Writes sterilization validation protocols and final reports.
• Coordinates and executes sterilization validations, incl. requalification and dose audits.
• Monitors environmental monitoring for cleanrooms.
• Documents product adoption into EO sterilization cycles.
• Interfaces with contract sterilizers and laboratories.
• Works independently; seeks guidance for complex issues as needed.
• May supervise technicians on the team.
• Completes investigations and dispositions of complex NCs.
• Manages compliance to Sterility Assurance and environmental metrics.
• Writes ECNs and leads continuous improvement projects.
• Oversees Environmental Monitoring programs for cleanrooms.
• Supports internal and external audits.

Skills

Analytical skills

MS Office

Team player

Interpersonal skills

Problem solving

Education

Bachelor’s Degree in Engineering or technical field related to the department

Tools

Spreadsheets

Word processing

Database software

ECN writing

Job description

Work Shift

DAY

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 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

COMPETENCIES

• Plans/surveys/structures/equipment
• Special projects/ECN's/prototype creation
• NCMR causes/corrective actions/dispositions
• Leadership

Infectious Control Risk Category II

The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category II states employment and procedures that may require exposure.

As an eligible Merit employee, you can expect the following:

• Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights
• Medical/Dental & Other Insurances (eligible the first of month after 30 days)
• Low Cost Onsite Medical Clinic
• Two (2) Onsite Cafeterias
• Employee Garden | Gardening Classes
• 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
• 401K | Health Savings Account

Merit is a proud Utah Patriot Partner committed to hiring our Veterans.