Quality Systems Manager

3 days ago

San Francisco, California, United States MICRON PRODUCTS Full time
Job Title: Quality Systems Manager

At Micron Solutions, we are seeking a highly skilled Quality Systems Manager to join our team. As a key member of our quality team, you will be responsible for ensuring the quality of our products and services meets the highest standards.

Job Summary

The Quality Systems Manager will oversee daily document control activities, participate in internal auditing, and ensure compliance with ISO 13485 and CFR 820 quality assurance requirements. You will also be responsible for training new employees on quality system procedures and supporting other departments with process improvement activities.

Key Responsibilities
  • Oversee daily document control activities, including processing and distributing documents, and maintaining document control records.
  • Participate in internal auditing, including conducting audits, identifying areas for improvement, and implementing corrective actions.
  • Ensure compliance with ISO 13485 and CFR 820 quality assurance requirements, including maintaining records and reporting to regulatory agencies.
  • Train new employees on quality system procedures, including document control, auditing, and quality data analysis.
  • Support other departments with process improvement activities, including identifying areas for improvement and implementing changes.
  • Compile certification documents, perform final packaging and labeling audits, and release products for shipment.
  • Coordinate document change activities, including processing and distributing changes, and maintaining records.
  • Liaise with regulatory reporting agencies and environmental consultants to ensure compliance with regulatory requirements.
  • Monitor quality systems through trending analysis, compiling metrics, and developing reports on a regular basis.
  • Perform and document customer complaint investigations, and assist the Quality Manager with findings to ensure effective actions are taken.
  • Provide support to manufacturing, project, and product development activities, including creating baseline pFMEA, validation plans and protocols, and DMRs.
  • Act as a gatekeeper between engineering and operations for new product introduction, ensuring compliance to Micron's processes.
  • Provide training support in the areas of ISO 13485, CFR 820 standards, Micron Quality System requirements, auditing, statistical process control, and vendor onboarding.
  • Support the corrective and preventive action process, including conducting root cause analysis, assisting in action plan creation, and implementing corrective actions.
  • Perform vendor onboarding and periodic assessments for critical materials, including assessing vendor QMS systems and evaluating their capability to produce materials or components.
Requirements
  • 10+ years of similar work experience.
  • Bachelor of Science degree preferred.
  • Ability to read and interpret engineering drawings.
  • Detailed understanding of regulatory and compliance protocols for ISO 13485 and cGMP 21 CFR part 820.
  • Must be able to read, write, and speak English fluently.
  • Must be capable of developing procedures, work instructions, flow charts, and forms in support of quality system requirements.
  • Strong facilitation, communication, and training skills are strongly recommended.
  • Proficiency in the use of computers, specifically Microsoft Office programs, is required.
  • Experience with IQMS ERP is a plus.

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