Quality Systems Leader — ISO 9001 & MasterControl

KINOVATE LIFE SCIENCES, INC; Carlsbad (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Kinovate Life Sciences, Inc. is seeking a Senior Quality Systems Specialist to champion and continually improve the QMS. You will collaborate with leadership to sustain ISO 9001:2015 and cGMP compliance, support audits, and administrate MasterControl while guiding staff across the organization.

The role emphasizes root cause analysis, training, and ongoing improvements in a regulated manufacturing environment, with onsite work in Carlsbad, CA.

Qualifications

• Bachelor's degree in a scientific discipline with 5+ years in ISO-regulated quality systems.
• Experience conducted internal and external audits and implementing corrective actions.
• Experience migrating from paper-based QMS to electronic QMS is preferred.

Responsibilities

• Lead development and management of the QMS in compliance with ISO 9001 and cGMP.
• Serve as MasterControl system administrator and train staff on QMS requirements.
• Manage document control: creation, revision, distribution, and archival of records.
• Conduct internal audits and support supplier qualification and supplier management.
• Perform root cause analysis for quality events and deviations.
• Provide QMS training and maintain training records.
• Act as SME for quality systems inquiries and support customer questionnaires.

Skills

Quality Systems

ISO 9001:2015

Internal Audits

MasterControl

QMS Training

Root Cause Analysis

Document Control

Regulatory Compliance

Supplier Qualification

Education

Bachelor's degree in a scientific discipline

Tools

MasterControl

NetSuite

EQMS/EDMS

Excel

Word

PowerPoint

Job description

Kinovate Life Sciences, Inc. is seeking a Senior Quality Systems Specialist to champion and continually improve the QMS. You will collaborate with leadership to sustain ISO 9001:2015 and cGMP compliance, support audits, and administrate MasterControl while guiding staff across the organization.

The role emphasizes root cause analysis, training, and ongoing improvements in a regulated manufacturing environment, with onsite work in Carlsbad, CA.