Business Strategy, Code of Federal Regulations, Consulting, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Customer Support/Service, External Audit, FDA (Food and Drug Administration), ISO (International Organization for Standardization), Internal Audit, Maintain Compliance, Manufacturing, Operational Strategy, Procedural Programming Languages, Procedure Development, Process Control Engineering, Process Improvement, Professional Services, Quality Engineering, Quality Management, Regulations, Regulatory Compliance, Regulatory Requirements, System Operations, System Readiness Review (SRR), Technical Support
For further inquiries about this opportunity, please contact one of our Talent Specialists, Justeen at (224) 394 4903 or Ragu at (224) 704-1713
Title: Staff Operational Compliance Specialist
Duration: 12 Months with possibility of extension and conversion to full-time
Location: San Diego, CA
Hours: 8 AM to 5 PM with possible overtime
Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.
Description:
Where you come in:
- 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.
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.
Work-related years of experience: 10+ Years
Required Skills :(top 3 non-negotiables):
1. Expertise in 21 CFR 820 and ISO 13485
2. Quality Management System understanding
3. Design Controls Experience
Preferred Skills (nice to have):
1. Remediation, Warning Letter, 483
2. Non-Product Software
Education: Requires a Bachelor's degree (B.S in Science of Engineering)
Software Skills Required:
1. Basic computer skills
2. Excel
Interview Format: On Site
About us:
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.