Quality Assurance Engineer I

Merit Medical Systems; Tijuana; On-site; MXN 240,000 - 300,000; Full time

Benefits offered by this job

Medical Insurance

Onsite Clinic

Cafeterias

Job summary

Merit Medical Systems is seeking a Quality Assurance Engineer I to perform routine engineering tasks within established methods and to support risk management for assigned product lines at our Tijuana site.

The role emphasizes adherence to 21 CFR 820, ISO 13485, and related medical device standards, with opportunities to participate in ECNs, supplier audits, and CAPA activities. Onsite work with cross-functional collaboration is required.

Qualifications

• Bachelor's degree in Quality Engineering or related field; Master’s preferred.
• Strong interpersonal, organizational, and verbal/written communication skills.
• Knowledge of 21 CFR 820, ISO 13485, and other medical device standards.

Responsibilities

• Perform routine engineering work using standard techniques and criteria.
• Assist with risk management and failure mode analysis for product lines.
• Review ECNs and update verification, validation, and inspection methods.
• Participate in supplier quality audits and containment of nonconforming product.
• Support CAPA investigations and corrective actions within QMS.

Skills

Quality engineering

ISO 13485

21 CFR 820

Six Sigma

Data analysis

CAPA

Quality systems

Education

Bachelor's degree in Quality Engineering

Master's degree

Tools

Excel

Crystal Reports

Oracle

Quality management software

Job description

## Quality Assurance Engineer IApply: Onsite: Tijuana, Mexico: Full time: Posted Today: JR117360**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 PERFORMED1. Performs routine engineering work requiring the application of standard techniques, procedures, and criteria in carrying out engineering tasks. 2. Uses limited amounts of discretionary judgment in making decisions regarding engineering alternatives. 3. Performs work of some higher technical level for training purposes, and work is screened to ensure correct application of scientific principles. 4. Responsible for risk management documentation for assigned product line(s) or processes; and identifying and updating failure modes and related process/product improvements by facilitating teams and implementing required changes. 5. Reviewing, approving and generating Engineering Change Notifications (ECNs) to update or generate: verification, validation, monitoring and inspection methods, procedures, and test protocols; specific to assigned product line(s) and processes and production control(s). 6. Evaluating and participating in the selection of suppliers by monitoring supplier performance, through collection and trending of data and performing supplier quality audits, as required. 7. Reviewing nonconformance records (internal/external) to determine: disposition, root cause and need for corrective and preventive actions. 8. Ensuring containment (identification, segregation and reconciliation) of nonconforming product has been performed, to prevent unintended use. 9. Identifying and implementing any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system through the use of: quality policy, quality objectives, audit results, analysis of data, etc. 10. Evaluating the work environment, in which product is manufactured, is adequately environmentally controlled and monitored, with sufficient personnel and safety production controls. 11. May participate in design and development activities. 12. Performs other related duties and tasks as required.ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS• Lifting -- Not to exceed 50 lbs. – local practice may apply. • Writing • Sitting • Standing • Bending • Vision • Color perception • Depth perception • Reading • Field of vision/peripheral • Fine motor skills • Noise • Chemical vaporsSUMMARY OF MINIMUM QUALIFICATIONS• Education and/or experience equivalent to a Bachelors Degree in Quality Engineering or related field, or a Masters Degree. • Strong interpersonal, organizational, and verbal and written communication skills and the ability to work effectively as a team member. • Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, and other medical device related standards. • Proven ability to work effectively in a team environment through conflict resolution and negotiations. • Working knowledge of statistical methodologies, quality control and manufacturing tools, such as applied statistics, lean manufacturing, Six Sigma, etc. • Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.PREFERRED QUALIFICATIONS• Medical device experience or equivalent experience in a regulated industry. • Experience with SmartCAPA, Oracle and Crystal Reports. • Experience handling deviations, investigations and CAPAs.COMPETENCIES• Standard engineering techniques/procedures/criteria • Special projects/ECN's • NC causes/corrective actions/dispositionsCOMMENTSInfectious 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.**