Sterility Assurance Engineer II

200 Merit Maquiladora Mexico, S. DE R.L. DE C.V.; Tijuana; On-site; MXN 300,000 - 500,000; Full time

Benefits offered by this job

Medical/Dental Insurance

Onsite Medical Clinic

Onsite Cafeterias

Vacation & Holidays

Job summary

Merit Medical in Tijuana, Mexico, is seeking a Sterilization Validation/QA professional to write protocols, coordinate validations, and monitor cleanroom environmental programs. You will collaborate with contract sterilizers, document investigations, and help lead continuous improvement efforts.

The role requires a engineering/technical degree with five years’ related experience, strong analytical skills, and the ability to work as part of a team in a regulated environment.

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.
• Analytical skills and scientific technical problem solving.
• Demonstrated computer skills with spreadsheets, word processing, database software.

Responsibilities

• Writes sterilization validation protocols and final reports.
• Coordinates and executes sterilization validations and requalifications as needed.
• Monitors the environmental monitoring program for cleanrooms.
• Performs product adoptions into EO sterilization cycles using applicable standards.
• Interfaces with contract sterilizers and laboratories.
• May supervise technicians and complete investigations on NCs.

Skills

Analytical skills

Teamwork

Computer skills

Interpersonal skills

International standards

Education

Bachelor’s degree in Engineering or technical field

Tools

Spreadsheets

Word processing

Database

Job description

Work Shift: DAY Work 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 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

COMMENTS

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.

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

Military Veterans are encouraged to Apply.

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

Founded in 1987, Merit Medical Systems, Inc. is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 500 individuals. Merit employs approximately 6,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.

UNDERSTAND. INNOVATE. DELIVER. Merit Medical is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit has made it a priority to understand customers, innovate, and deliver life-changing products and services.