Quality Engineer

hace 7 días

Reynosa, México BD A tiempo completo

**Job Description Summary**: Assist the Quality Operations Manager in the development, installation, and operation of the Quality System for the economic control of the quality of raw materials in-process and finished products. Development and audit of inspection criteria or methods, technical and statically investigation on quality problems and complaints, product, process and test method validation, corrective actions among others. Play key role in ensuring that the corporation and customer’s quality requirements are meet on assigned areas.

**Responsibilities**:

- Solve de manufacturing and quality problems, support the manufacturing operation and responsible for quality improvement.
- Demonstrate ability to assimilate and define problems.
- Implement appropriate and efficient corrective actions to avoid problems.
- Responsible for process optimization, scrap reduction and cost reduction.
- Responsible for product and process validations within the facility and external suppliers (PQ), including testing, equipment, and tooling (IQ).
- Interact with corporate and divisional personnel to clarify specifications, product design changes, quality issues and technology transfers.
- Lead the product and process transfer; responsible to meet the transfer due date, smooth transfer without major quality issues.
- Responsible to develop and maintain the quality and monitoring the manufacturing documentation to comply with our standards.
- Support the Quality Engineer Manager and Quality Manager in the budget activities.
- Investigates root cause of quality problems and complaints using statistical techniques (DOE, ANOVA, Regression Analysis, etc.).
- Improve manufacturing, inspection, and test documentation to ensure that customer requirements are met.
- Ensure GMP regulations and ISO and corporate guidelines are followed.
- Responsible for the technical Supervisor on the In-Process Inspection of their assigned lines.
- Responsible to analyze areas of opportunities (NC) for their areas and assure that the action taken are to focus on the Root cause and proposes new method to improve manufacturing process.
- Evaluate customer complaints received from Divisions.

**Requirements**:

- Bachelor's Degree in Engineering; Master's Degree in Quality desired.
- 5 years or more related experience in quality systems and medical device manufacturing processes.
- Knowledge in GMP, ISO BSI mark compliance and FDA regulations, experience with medical device manufacturing process.
- Strong computer skills, ideally with experience using Windows-based PC programs. Use of Minitab or other equivalent statistical software.
- Excellent communication, organizational, change management, and problem-solving skills
- Ability to handle multiple tasks, with awareness of deadlines.
- Dynamic. Sense of urgency.
- Positive attitude with good interpersonal and organizational skills, proficient, ability to solve problems, responsible, ability to work under pressure.
- Able to communicate both verbally and in writing in English.

**Primary Work Location**: MEX Reynosa

**Additional Locations**:
**Work Shift**:

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