The Quality Engineer will be based Tijuana. This position will be focused on: Maintains quality engineering programs, standards and improvements within the organization.
We are looking for someone who demonstrates:
- Intense collaboration
- Passionate customer focus
- Thoughtful, fast, disciplined execution
- Tenacious commitment to continuous improvement
- Relentless drive to win
Here is a glimpse of what you'll do:
- Develops and initiates standards and methods for inspection, testing and evaluation.
- Develops and initiates standards and methods for Laboratory Chemical inspection, testing and evaluation.
- Devises sampling procedures and designs and develops forms and instructions for recording.
- Develops and implements methods for disposition of discrepant material and devises methods to assess cost and responsibility
- Writes training material and conducts training sessions on quality control activities.
- Supports quality program managers with customer interfaces as necessary on quality related issues.
- Initiates corrective action requests as needed and tracks to satisfactory completion.
- Assist with development and implementation of quality audits.
- Analyzes reports and returned products and recommends corrective action.
- Approves product, process and equipment qualifications.
- Provides liaison to various regulatory bodies and Assures data availability and integrity for all quality related data.
Here is some of what you'll need (required):
- Knowledge in Quality Systems.
- An excellent understanding and practical application of medical device quality system regulations, e.g., 21 CFR 820, ISO 13485 and ISO 14971
- Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required Experience in Measurement System Analysis, SPC, DOEs, Reliability
- NCMRs and CAPAs management
- Production floor support
- Personnel management
- Knowledge in management of corrective actions, Root Cause containment actions
- Validations IQ, OQ and PQ
- Validation of first articles
- Development of documents for inspection / quality
- Handling customer complaints
- Management of discrepancies in the NCMR process
- Non-conforming material MRB
- Presentation of quality metrics to the client
- Advanced English
Here are a few of our preferred experiences:
- Requires a Bachelor´s degree in engineering or equivalent experience
- Typically requires 2 years of experience in engineering in the high technology electronics industry or related field.
- Ability to apply statistical tools.
- Ability to define problems collects data, establish facts and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form.
- Ability to use the tools, testing, inspection, Electronical tools, office skills.
- Ability to read and interpret documents such as safety rules.
- Ability to write routine reports and correspondence.
- Impacts operations of immediate work group.
Here are a few examples of what you'll get for the great work you provide:
- Pantry vouchers
- Saving Fund
- Christmas bonus
- Holiday bonus
- Medical Insurance
- Life Insurance
The information we collect:
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