Senior Quality Systems Specialist - Med Tech Compliance

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

Job summary

Orthofix in Carlsbad, CA, is seeking a Senior Quality Systems Specialist to ensure the Quality System complies with US and international standards. The role includes audits, CAPA, documentation control, LMS and PLM support, and GUDID regulatory tasks.

You will drive continuous quality improvements and collaborate with cross-functional teams to uphold compliance. The ideal candidate has 3–5 years in QA/QC, strong knowledge of FDA QSRs, ISO 13485/14971, and experience with electronic quality tools

Qualifications

• 3-5 years’ experience in a QA or QC environment.
• Knowledge of FDA Quality System Regulations (21 CFR 801, 803, 806, 807, 820).
• Experience implementing electronic Quality System tools.
• Ability to maintain and improve Quality Management System processes.

Responsibilities

• Enhance Quality Management System and related SOPs.
• Design and deliver QMS training and maintain training records.
• Manage internal audits, CAPA, and document control activities.
• Support GUDID data submission and labeling activities.
• Collaborate cross-functionally to ensure regulatory compliance.

Skills

QA/QC experience

Cross-functional collaboration

Excellent communication skills

Analytical skills

Time management

Education

High School Diploma or equivalent

Bachelor’s Degree (preferred)

Engineering or scientific discipline (preferred)

Tools

Agile

Reliance EtQ

MasterControl

Oracle

Pilgrim

LMS systems

PLM systems

Job description

Orthofix in Carlsbad, CA, is seeking a Senior Quality Systems Specialist to ensure the Quality System complies with US and international standards. The role includes audits, CAPA, documentation control, LMS and PLM support, and GUDID regulatory tasks.

You will drive continuous quality improvements and collaborate with cross-functional teams to uphold compliance. The ideal candidate has 3–5 years in QA/QC, strong knowledge of FDA QSRs, ISO 13485/14971, and experience with electronic quality tools