Junior QA Engineer – Medical Devices

Merit Medical Systems; Tijuana; Híbrido; MXN 420.000 - 580.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical Insurance

Onsite Cafeterias

Paid Holidays

401K

Onsite Clinic

Descripción de la vacante

Merit Medical Systems seeks a Quality Engineer in an on-site role in the Tijuana facility. The candidate will apply standard engineering techniques to product quality, manage ECNs, and support risk management for medical devices. Strong teamwork and knowledge of CFR 820 and ISO standards are required.

Experience with supplier audits, CAPAs, and statistical methods is preferred. You will contribute to continuous improvements, containment of nonconforming products, and maintenance of the quality

Formación

• 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.

Responsabilidades

• Performs routine engineering work requiring the application of standard techniques, procedures, and criteria in carrying out engineering tasks.
• Uses limited amounts of discretionary judgment in making decisions regarding engineering alternatives.
• Performs work of some higher technical level for training purposes, and work is screened to ensure correct application of scientific principles.
• 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.
• 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).
• 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.
• Reviewing nonconformance records (internal/external) to determine: disposition, root cause and need for corrective and preventive actions.
• Ensuring containment (identification, segregation and reconciliation) of nonconforming product has been performed, to prevent unintended use.
• 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.
• Evaluating the work environment, in which product is manufactured, is adequately environmentally controlled and monitored, with sufficient personnel and safety production controls.
• May participate in design and development activities.
• Performs other related duties and tasks as required.

Conocimientos

Interpersonal skills

Verbal communication

Written communication

Educación

Bachelor's in Quality Engineering or related field

Master's degree

Herramientas

Statistics

Lean Manufacturing

Six Sigma

Descripción del empleo

Merit Medical Systems seeks a Quality Engineer in an on-site role in the Tijuana facility. The candidate will apply standard engineering techniques to product quality, manage ECNs, and support risk management for medical devices. Strong teamwork and knowledge of CFR 820 and ISO standards are required.

Experience with supplier audits, CAPAs, and statistical methods is preferred. You will contribute to continuous improvements, containment of nonconforming products, and maintenance of the quality