Quality Compliance Specialist

FLEX Ltd

Aguascalientes, Mexico
Competitive salary; christmas bonus included; bene...
Process validation principles iq oq pq
Iso 13485 and iso 9001 knowledge
Strong written and verbal communication skills
The role involves planning and coordinating the internal validation process to ensure alignment with external customer requirements and operational optimization

Job Summary

  • The role involves planning and coordinating the internal validation process to ensure alignment with external customer requirements and operational optimization.
  • Candidates must ensure that validation documentation complies with applicable ISO 13485 / ISO 9001 requirements, internal procedures, and regulatory standards.
  • The company offers a competitive salary, life & medical insurance, Christmas bonus, food coupons, and a saving fund.

Matching Summary

The role involves planning and coordinating the internal validation process to ensure alignment with external customer requirements and operational optimization.

Salary

Competitive Salary; Christmas Bonus included; Benefits: Life & Medical insurance, Food Coupons, Saving Fund

Skills & Requirements

Must-have

  • Process validation principles IQ OQ PQ
  • ISO 13485 and ISO 9001 knowledge
  • Strong written and verbal communication skills
  • Review of validation protocols and documentation
  • Cross-functional team coordination abilities

Nice-to-have

  • Basic understanding of statistical concepts
  • Attention to detail in document review
  • Knowledge of data integrity principles
  • Good documentation practices GDP awareness
  • Effective time management and prioritization

Key Requirements

  • Industrial Engineering or similar degree
  • Advanced English proficiency required
  • Experience with FDA 21 CFR Part 820 preferred

Work Rights

Not specified

Tailored Resume

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