The Quality Engineer (ISO-13485) will be based Tijuana B.C., Experience working with project management, Develops and initiates standards and methods for inspection, testing and evaluation and Assist with development and implementation of quality audits.
We are looking for someone who demonstrates :
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.
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.
Assures data availability and integrity for all quality related data. Consolidates and reports quality results
Here is some of what you’ll need (required) :
Knowledge in Quality Systems.
5-7 years of experience as a Quality Engineer
3 years of experience with project management
5 years working on medical industry
Knowledge in ISO-13485
Experience in PQ, OQ and IQ validations
Knowledge with statistical tools
NCMRs and CAPAs management
Here are a few of our preferred experiences :
Requires a Bachelor s degree or equivalent experience in addition 2 years’ experience.
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 :
QualityFlex does not accept unsolicited resumes from headhunters, recruitment agencies or fee based recruitment services.
Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities.
Flex does not discriminate in employment opportunities or practices on the basis of : age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status or any other status protected by law.
Flex provides reasonable accommodation so that qualified applicants with a disability may participate in the selection process.
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com. Please state your request for assistance in your message. Only reasonable accommodation requests related to applying for a specific position within Flex will be reviewed at the e-
mail address. Flex will contact you if it is determined that your background is a match to the required skills required for this position.
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