Staff Operational Compliance Specialist

Staff Operational Compliance Specialist
12 Months
San Diego CA

Must haves

• Expertise in 21 CFR 820 and ISO 13485
• Quality Management System understanding
• Design Controls Experience

Job Description

• You serve as the Staff Operational Compliance Specialist on key project teams, providing expertise in Quality Systems, Regulatory Compliance, and operational excellence.
• You drive operational compliance initiatives, including system remediation, process improvement, quality system reviews, and audit readiness activities.
• You proactively identify compliance and procedural gaps across programs or sites and lead corrective and preventive actions to drive sustainable improvement.
• You provide expert-level guidance in strengthening and governing the Quality Management System, including CAPA strategy, nonconformance management, process controls, and continuous improvement initiatives.
• You partner with cross-functional teams to ensure compliance with FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
• You represent the organization during internal audits and external regulatory inspections, supporting inspection readiness and regulatory responses.
• You ensure adherence to Quality Compliance and Regulatory Compliance requirements across products, processes, and systems.
• You drive enhancements within Design Controls, Pilot Manufacturing, and Manufacturing environments to improve compliance, quality system effectiveness, and operational performance.

Preferred experience includes Quality Engineering, Design Controls, Manufacturing, and Validation activities.
Work related years of experience: 10+ years

Education
B.S in Science of Engineering

Day to Day Responsibilities

• Operational compliance including:
• System remediation
• Process improvement
• Quality system reviews
• Audit readiness
• Driving enhancements in the Design Controls, Pilot Manufacturing, and Manufacturing space.

Preferred Skills 

• Remediation, Warning Letter, 483
• Non-Product Software

 

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's pay range is $55.00/hr – $65.00/hr.