QA Manager – Medical Devices (Stock & Bonus)

SI-BONE; Santa Clara (CA); On-site; USD 141,000 - 155,000; Full time

Benefits offered by this job

Bonus

Stock

Job summary

SI-BONE is seeking a Quality Assurance Manager to lead the QC group, ensure FDA and ISO compliance, and drive process improvements across quality systems and supplier controls.

The role requires 6+ years in regulated environments, a technical engineering degree, and strong leadership capabilities. Competitive salary and supplemental pay offered; on-site in Santa Clara, CA with cross-functional collaboration.

Qualifications

• 6+ years of directly relevant experience in FDA/cGMP or other regulated environments.
• Bachelor's degree in engineering or technical science.
• ASQ CQE certification preferred.
• Knowledge of FDA QMSR, ISO 13485, MDR, MDSAP.
• Experience with Design Control, Quality Control, Production Process Controls, Supplier Controls, CAPA/Non-Conformance.
• Knowledge of ERP systems (QAD) and statistical quality tools.

Responsibilities

• Manage quality control group for inspection of materials and final release.
• Lead and mentor QC Inspectors; review lot history records and RMA returns.
• Coordinate with logistics on parts prioritized for release; ensure FDA/ISO compliance.
• Support supplier audits, supplier evaluations, and corrective actions.
• Oversee quality systems, audits, CAPA process and preventative maintenance.
• Create and monitor quality metrics; report through statistical/operational data.

Skills

Verbal & written communication

Team player

Problem solving

Education

B.S. in Engineering/Technical Science

ASQ CQE certification (preferred)

Tools

QAD ERP

Statistical quality tools

Job description

SI-BONE is seeking a Quality Assurance Manager to lead the QC group, ensure FDA and ISO compliance, and drive process improvements across quality systems and supplier controls.

The role requires 6+ years in regulated environments, a technical engineering degree, and strong leadership capabilities. Competitive salary and supplemental pay offered; on-site in Santa Clara, CA with cross-functional collaboration.