Quality Assurance Engineer I

Merit Medical Systems, Inc.; Tijuana; Presencial; MXN 400.000 - 700.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Multiple shifts

Medical & dental insurance

Onsite medical clinic

Onsite cafeterias

Paid vacation & holidays

401K

Descripción de la vacante

Merit Medical Systems, Inc. seeks a Quality Engineer to support regulatory compliance and continuous improvement in our Baja California operations.

Responsibilities include risk management, ECOs, supplier quality, CAPA, and maintaining the QMS per 21 CFR 820 and ISO 13485, with opportunities to participate in design and development activities.

Formación

• Education and/or experience equivalent to a Bachelor's Degree in Quality Engineering or related field, or a Master's Degree.
• Strong interpersonal, organizational, and verbal and written communication skills.
• 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.

Responsabilidades

• Performs routine engineering work using standard techniques and criteria in engineering tasks.
• Reviews, approves and generates ECNs to update verification, validation, monitoring and inspection methods and test protocols.
• Evaluates supplier performance and conducts supplier quality audits as required.
• Reviews nonconformance records to determine disposition and root cause for CAPA actions.
• Ensures containment of nonconforming product to prevent unintended use.
• Participates in design and development activities as needed.

Conocimientos

Interpersonal skills

Organizational skills

Verbal communication

Written communication

Educación

Bachelor's Degree in Quality Engineering or related field

Master's Degree

Herramientas

Statistical methods

Lean manufacturing

Six Sigma

CAPA management

ECN processing

Descripción del empleo

Work Shift:

DAY

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. 1. Performs routine engineering work requiring the application of standard techniques, procedures, and criteria in carrying out engineering tasks.
2. 2. Uses limited amounts of discretionary judgment in making decisions regarding engineering alternatives.
3. 3. Performs work of some higher technical level for training purposes, and work is screened to ensure correct application of scientific principles.
4. 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. 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. 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. 7. Reviewing nonconformance records (internal/external) to determine: disposition, root cause and need for corrective and preventive actions.
8. 8. Ensuring containment (identification, segregation and reconciliation) of nonconforming product has been performed, to prevent unintended use.
9. 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. 10. Evaluating the work environment, in which product is manufactured, is adequately environmentally controlled and monitored, with sufficient personnel and safety production controls.
11. 11. May participate in design and development activities.
12. 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.