Quality System Specialist- Product Release

BD

Anasco, PR, USA
Fully remote
Review device history records dhrs
Verify quality control checks results
Knowledge of fda 21 cfr part 820
BD is seeking a Quality System Specialist - Product Release to ensure timely and compliant release of medical products in Anasco, PR. The role involves reviewing documentation to uphold quality and regulatory standards and offers a collaborative environment for professional growth

Job Summary

  • The role ensures timely and compliant release of manufactured products by meticulously reviewing documentation and verifying adherence to quality system requirements.
  • Candidates must have a demonstrated knowledge of Quality System Regulations including FDA 21 CFR Part 820 and ISO 13485.
  • BD prioritizes on-site collaboration requiring a minimum of 4 days of in-office presence per week to foster creativity and innovation.

Matching Summary

Match Score: 85

BD is seeking a Quality System Specialist - Product Release to ensure timely and compliant release of medical products in Anasco, PR. The role involves reviewing documentation to uphold quality and regulatory standards and offers a collaborative environment for professional growth.

Skills & Requirements

Must-have

  • Review device history records DHRs
  • Verify quality control checks results
  • Knowledge of FDA 21 CFR Part 820
  • Experience with ISO 13485 standards
  • Resolve discrepancies and non-conformances

Nice-to-have

  • Proficiency in SAP ERP systems
  • Experience with Quality Management Systems
  • Strong analytical skills for documentation
  • Ability to work independently in fast-paced environment

Key Requirements

  • Bachelor's degree in sciences or equivalent
  • Minimum 2 years regulated manufacturing experience
  • Medical device or pharmaceutical industry background preferred

Work Rights

Not specified

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