Senior Quality Assurance Specialist
hace 1 día
**Quality Engineer Job Summary**
We are seeking a skilled Senior Quality Assurance Specialist to join our team in Reynosa, Mexico. This is an exciting opportunity for someone with experience in quality systems and medical device manufacturing processes.
Key Responsibilities:
- Collaborate with the Quality Operations Manager to develop and implement quality systems for raw material and product control.
- Investigate quality problems and complaints using statistical techniques, and implement corrective actions to prevent future issues.
- Responsible for process optimization, scrap reduction, and cost reduction in assigned areas.
- Develop and maintain quality documentation to ensure compliance with standards and regulations.
- Support Quality Engineer Manager and Quality Manager in budget activities and interact with corporate personnel to clarify specifications and quality issues.
- Analyze areas of opportunities (NC) for assigned areas and propose new methods to improve manufacturing processes.
- Evaluate customer complaints received from Divisions and ensure GMP regulations and ISO guidelines are followed.
Requirements:
- Bachelor's Degree in Engineering or Master's Degree in Quality desired.
- 5 years or more related experience in quality systems and medical device manufacturing processes.
- Knowledge of GMP, ISO BSI mark compliance, and FDA regulations.
- Strong computer skills and experience using Minitab or equivalent statistical software.
- Excellent communication, organizational, change management, and problem-solving skills.
- Able to handle multiple tasks and work under pressure.
- Dynamic and positive attitude with good interpersonal and organizational skills.
- Proficient in both verbal and written English communication.
Estimated Salary Range:$80,000 - $110,000 per year
Primary Work Location:MEX Reynosa
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