Job Description Summary

Develop and sustain quality system processes for the Design Center that comply with applicable regulations and standards, Corporate and Business Unit policies and procedures. Identify gaps in existing practices against the procedures and close those gaps.

Job Description

Responsibilities

• Develop, modify and maintain quality system procedures for the design center that comply with ISO 13485:2016 and 21 CFR 820 requirements
• Implement Corporate and Business level Quality System procedures for the design center locations
• Lead or facilitate internal quality system audits per the procedural requirements
• Lead the management of external audits
• Lead the development of content for the management review process
• Update and report on monthly quality metrics
• Provide inputs on revisions to Corporate and Business level procedures as necessary
• Support supplier management efforts for the design center
• Maintain outsourcing relationships with internal customers and suppliers by management of quality agreements

Sphere of Influence

• Considered as a Subject Matter Expert for QMS processes
• Work is performed without appreciable direction
• Determine and pursue course of action necessary to obtain desired results

Minimum Requirements

• A minimum of Bachelor’s degree in Science or related discipline
• Certified ISO 9001/13485 Lead auditor
• Strong knowledge of Design Control, Risk Management and QMS processes
• Minimum 5 years of experience supporting design assurance for medical devices
• Exposed to internal and external audits as an auditor and/ or auditee
• Extensive knowledge of applicable regulatory and industry standards (21 CFR 820, ISO 13485, MDD, MDR, ISO 14971, etc.)
• Good technical writing and communication skills

Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

USA CA – Brea

Work Shift