Quality Systems Leader: Regulatory Compliance & Audits

Orthofix Holdings, Inc.; Carlsbad (CA); On-site; USD 101,953 - 131,017; Full time

Job summary

Orthofix Holdings, Inc. in Carlsbad, CA seeks a Senior Quality Systems Specialist to ensure the Quality System complies with domestic and international standards. You will drive audits, maintain documentation, and support LMS/PLM systems for compliant operations.

The role requires 3–5 years in QA/QC, strong regulatory knowledge (FDA QSR, ISO 13485/14971), and hands-on experience with electronic QMS tools and cross-functional collaboration.

Qualifications

• 3-5 years’ experience in a QA or QC environment.
• Experience implementing Quality Management Systems in regulated medical device/diagnostic companies.
• Expert knowledge of US FDA QSR (21 CFR 801, 803, 806, 807, 820).
• Experience with electronic QMS tools (e.g., MasterControl, EtQ Reliance).
• Ability to operate in cross-functional teams and communicate effectively.

Responsibilities

• Perform internal audits to ensure annual coverage of quality elements.
• Administer and evaluate QMS training programs.
• Lead document control activities and GUDID-related tasks.
• Support external audits by FDA or Notified Bodies.
• Coordinate CAPA activities and post-market surveillance tasks.

Skills

QMS knowledge

Audit experience

Regulatory compliance

Cross-functional teamwork

cGMP training

Data analysis

Education

Bachelor’s degree in engineering or scientific discipline

High School Diploma or equivalent

Tools

MasterControl

EtQ Reliance

Oracle

Pilgrim

Job description

Orthofix Holdings, Inc. in Carlsbad, CA seeks a Senior Quality Systems Specialist to ensure the Quality System complies with domestic and international standards. You will drive audits, maintain documentation, and support LMS/PLM systems for compliant operations.

The role requires 3–5 years in QA/QC, strong regulatory knowledge (FDA QSR, ISO 13485/14971), and hands-on experience with electronic QMS tools and cross-functional collaboration.