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Sr Process Engineer
hace 2 semanas
Department:
Operations
Location:
MEX-Juarez-Plant #2 P
Compensation:
$57,282 - $70,000 / month
Description
Responsible for process improvement, identification of process control parameters, monitoring, and taking measures to prevent and/or correct issues with processes. Conducts technical investigations of customer complaints related to product and process issues. May conduct internal audits. Participates in customer complaint follow-up and CAPA program investigations. Supports ongoing production activities and participates in the development of new technologies. Collaborates in the design and execution of process improvements and validations.
Key Responsibilities
- Implement and maintain process controls and monitoring systems.
- Develop testing and inspection methods.
- Conduct validations of test methods, Gauge R&R, etc.
- Develop and implement real-time, statistically-based process control and system methodologies to eliminate reliance on product inspection and drive continuous improvement of product and quality processes.
- Lead internal multidisciplinary teams based on process development and improvement efforts.
- Coordinate risk assessment of new products and processes.
- Conduct meetings and lead corrective and/or preventive action projects.
- Document, define, measure, and improve current manufacturing processes using statistical process control techniques and methodology.
- Ensure the use and application of the most appropriate manufacturing processes, techniques, and tools in terms of quality and productivity.
- Investigate, develop, refine, and apply new trends, methods, and technologies in manufacturing processes.
- Integrate and automate manufacturing systems and processes.
- Continuously implement process improvement methodologies and techniques.
- Establish robust process operation parameters to supervise and audit all processes, provide technical support to the manufacturing area and the development of new products.
- Develop and conduct training courses on process, equipment, and create corresponding training material.
- Optimize equipment utilization, determine and implement plant layout and material flow to optimize operations. Analyze, define, and implement material and equipment handling to improve operational profitability.
Skills, Knowledge & Expertise
- Engineering studies.
- Postgraduate studies (Desirable).
- 7-10 years of experience in mechanical or process engineering or related field (Desirable).
- Experience in the medical or pharmaceutical industry regulated by the FDA (preferably).
- Master Black Belt, Black or Green belt in Six Sigma (Desirable).
- Preferably knowledgeable in the following areas:
- ISO 13485
- JPAL (Japan Ministry of Health, Labor, and Welfare- Ordinance No. 169, 2004)
- SOR/ Canadian Medical Device Regulation)
- MDD 93/42/EEC (European Council Directive)
- U.S. Code of Federal Regulations
Specific Language Requirements
Intermediate English
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Equal Opportunity Statement
Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.
