Quality Assurance Engineer III

hace 3 semanas

Tijuana, Baja California, México Merit Medical Systems Inc. A tiempo completo
About Merit Medical Systems Inc.

Merit Medical Systems Inc. is a leading developer of innovative medical devices that improve lives. Our mission is to integrate and develop talented individuals who work together to create life-saving devices through hard work, teamwork, and commitment.

Our Vision

We strive to make a difference in the lives of patients around the world by developing and manufacturing high-quality medical devices.

Job Summary

We are seeking a highly skilled Quality Assurance Engineer III to join our team. The successful candidate will be responsible for evaluating, selecting, and applying standard engineering techniques, procedures, and criteria to ensure the quality of our medical devices.

Key Responsibilities
  1. Evaluate and select standard engineering techniques, procedures, and criteria to ensure the quality of our medical devices.
  2. Investigate and analyze engineering variables to complete assignments with clear and defined objectives.
  3. Work independently on standard projects while receiving assistance on unusual problems.
  4. Responsible for risk management documentation for assigned product lines or processes.
  5. Review, approve, and generate Engineering Change Notifications (ECNs) to update or generate verification, validation, monitoring, and inspection methods, procedures, and test protocols.
  6. Evaluate and participate in the selection of suppliers by monitoring supplier performance.
  7. Review nonconformance records to determine disposition, root cause, and need for corrective and preventive actions.
  8. Ensure containment of nonconforming product to prevent unintended use.
  9. Identify and implement changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system.
  10. Evaluate the work environment to ensure it is adequately environmentally controlled and monitored.
  11. May participate in design and development activities.
  12. Perform 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

Minimum Qualifications
  1. Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field with five years quality engineering experience.
  2. Strong interpersonal, organizational, and verbal and written communication skills and the ability to work effectively as a team member.
  3. Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, and other medical device-related standards.
  4. Proven ability to work effectively in a team environment through conflict resolution and negotiations.
  5. Working knowledge of statistical methodologies, quality control, and manufacturing tools, such as applied statistics, lean manufacturing, Six Sigma, etc.
  6. Demonstrated computer skills, preferably spreadsheets, word processing, database, and other applicable software programs.
Preferred Qualifications
  1. Medical device experience or equivalent experience in a regulated industry.
  2. Experience with SmartCAPA, Oracle, and Crystal Reports.
  3. Experience handling deviations, investigations, and CAPAs.
  4. Validations, product line transfer, and project management.
Competencies
  1. Engineering variable analysis
  2. Plans/surveys/structures/equipment
  3. Supervisory assistance
  4. Special projects/ECNs/prototype creation
  5. NC causes/corrective actions/dispositions
Benefits

As a member of Merit Medical, you are eligible for:

  • Life insurance, major medical expenses, and funeral expenses.
  • Extended medical coverage for family members.
  • Superior paid vacation days and holiday pay.
  • Two days of paid leave per year (one birthday and one floating holiday).
  • Two additional festive days (Good Friday and Christmas).
  • Unlimited savings fund.
  • Annual bonus for results.
  • Free meals.
  • Merit Academy - Continuous training.
  • Social Responsibility Committee.

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