Quality Assurance Engineer I

200 Merit Maquiladora Mexico, S. DE R.L. DE C.V.; Tijuana; Presencial; MXN 420.000 - 660.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical Insurance

Onsite Clinic

Vacation

401K

Paid Holidays

Descripción de la vacante

200 Merit Maquiladora Mexico, S. DE R.L. DE C.V. in Tijuana, MX is seeking a Quality Engineer to uphold medical device quality systems and ensure compliance with 21 CFR 820 and ISO standards.

You will lead risk management, review ECNs, coordinate CAPAs, and support supplier quality while working cross-functionally to drive continuous improvement; this is a full-time on-site role.

Formación

• Bachelor's degree in Quality Engineering or related field.
• Strong knowledge of 21 CFR 820 and ISO quality standards.
• Experience with CAPA, deviations, and risk management.
• Ability to work in a regulated medical devices environment.

Responsabilidades

• Perform risk management documentation for assigned product lines.
• Review ECNs and update test methods, validation, and verification protocols.
• Participate in supplier quality evaluations and audits.
• Review nonconformance records and determine dispositions.
• Ensure containment of nonconforming product to prevent use.
• Maintain QMS through data analysis, audits, and process improvement.
• May participate in design and development activities.

Conocimientos

21 CFR 820

ISO 13485

Six Sigma

Lean Manufacturing

Statistical Methods

Educación

Bachelor's degree in Quality Engineering

Masters degree desirable

Herramientas

SmartCAPA

Oracle

Crystal Reports

Descripción del empleo

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

1. 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 vapors

SUMMARY 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/dispositions

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. 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.

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.