QA Engineer II

Merit Medical; Tijuana; Presencial; MXN 732,000 - 1,100,000; Jornada completa

Descripción de la vacante

A prominent medical device company in Tijuana is seeking a Quality Engineer to support Post Market Surveillance initiatives. Responsibilities include quality documentation, supplier evaluation, and compliance with engineering standards. The ideal candidate has a Bachelor's Degree in Engineering, 3+ years in quality engineering, and experience in the medical industry. Strong English skills and analytical abilities are essential for success in this role.

Formación

• 3+ years of quality engineering experience.
• 2 years of Post Market Surveillance experience is a must.
• Advanced English level is required.
• Medical industry experience is a must.

Responsabilidades

• Perform routine and complex quality engineering work.
• Manage risk management documentation for product lines.
• Review and generate Engineering Change Notifications.
• Evaluate supplier performance through audits.

Conocimientos

Analytical skills

Interpersonal skills

Communication skills

Statistical methodologies

Lean manufacturing

Six Sigma

Educación

Bachelor's Degree in Engineering

Herramientas

SmartCAPA

Oracle

Crystal Reports

Descripción del empleo

JOB DESCRIPTION SUMMARY

JOB DESCRIPTION SUMMARY Provides routine and complex quality engineering work for specific product lines under broad supervision and guidelines.

ESSENTIAL FUNCTIONS PERFORMED

1. Mainly focused on Post Market Surveillance. This position will not be in production floor
2. Works independently on standard projects while assistance is furnished on unusual problems.
3. Receives instructions on specific assignment objectives, complex features and possible solutions.
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. Reviews, approves and generates 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. Evaluates and participates in the selection of suppliers by monitoring supplier performance, through collection and trending of data and performing supplier quality audits, 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 Bachelor's Degree in Engineering or related field with three years quality engineering experience
• Post Market Surveillance prior experience (2 years aprox)(must)
• Advanced English level(must)
• Strong analytical skills
• Experience closing non conformities
• Prior medical industry experience (must)
• 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

• Engineering techniques/evaluation/selection/application
• Engineering variable analysis
• Plans/surveys/structures/equipment
• Supervisory assistance
• Special projects/ECN's/prototype creation
• 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.