Sterility Assurance Engineer II

Merit-Medical-Systems-Inc.; Tijuana; On-site; MXN 400,000 - 800,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Onsite Medical Clinic

Two Onsite Cafeterias

Paid Vacation & Holidays

401K

Job summary

Merit Medical is seeking a Sterilization Validation Engineer in Mexico to write validation protocols and final reports, coordinate sterilization validations, and monitor cleanroom environmental monitoring programs. You will interface with contract sterilizers and laboratories and may supervise technicians.

Ideal candidates have a Bachelor's degree in Engineering and at least five years of related experience, plus strong analytical, problem-solving, and teamwork abilities.

Qualifications

• Bachelor’s Degree in Engineering or technical field related to the department with five years previous related experience.
• Ability to apply analytical skills and scientific principles in problem solving.
• Strong computer skills including spreadsheets and databases.

Responsibilities

• Writes sterilization validation protocols and final reports.
• Coordinates and executes sterilization validations and dose audits.
• Monitors the environmental monitoring program for the cleanrooms.

Skills

Analytical skills

Problem solving

Team player

Interpersonal skills

Computer skills

Education

Bachelor's Degree in Engineering

Tools

Excel

Database

Job description

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/peripheralSUMMARY 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/applicationCOMPETENCIES• Plans/surveys/structures/equipment• Special projects/ECN's/prototype creation• NCMR causes/corrective actions/dispositions• LeadershipCOMMENTSInfectious 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 AccountTo see more on our culture, go to www.merit.com/careers .Military Veterans are encouraged to Apply.Merit is a proud Utah Patriot Partner committed to hiring our Veterans.