Genesis10 is currently seeking a Staff Operational Compliance Specialist - Onsite position with a Global Medical Technology Company located in San Diego, CA. This is a 12+ month contract opportunity.
Pay range: $60.00 - $69.00 per hour As the Staff Operational Compliance Specialist, you will join key project teams to provide expertise in Quality Systems, Regulatory Compliance, and operational excellence. You will partner with cross-functional teams to ensure compliance with FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements. This role involves driving enhancements within Design Controls and Manufacturing environments to improve compliance and operational performance.
Responsibilities: - Serve as the Staff Operational Compliance Specialist on key project teams, providing expertise in Quality Systems, Regulatory Compliance, and operational excellence
- Drive operational compliance initiatives, including system remediation, process improvement, quality system reviews, and audit readiness activities
- Proactively identify compliance and procedural gaps across programs or sites and lead corrective and preventive actions to drive sustainable improvement
- Provide expert-level guidance in strengthening and governing the Quality Management System, including CAPA strategy, nonconformance management, process controls, and continuous improvement initiatives
- Partner with cross-functional teams to ensure compliance with FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements
- Represent the organization during internal audits and external regulatory inspections, supporting inspection readiness and regulatory responses
- Ensure adherence to Quality Compliance and Regulatory Compliance requirements across products, processes, and systems
- Drive enhancements within Design Controls, Pilot Manufacturing, and Manufacturing environments to improve compliance, quality system effectiveness, and operational performance
Requirements: - Requires a Bachelor's degree (B.S in Science or Engineering)
- 10 years of related work experience
Desired skills: - Experience in Quality Engineering, Design Controls, Manufacturing, and Validation activities
Only candidates available and ready to work directly as Genesis10 employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, please apply! Ranked a Top Staffing Firm in the U.S. by Staffing Industry Analysts for six consecutive years, Genesis10 puts thousands of consultants and employees to work across the United States every year in contract, contract-for-hire, and permanent placement roles. With more than 300 active clients, Genesis10 provides access to many of the Fortune 100 firms and a variety of mid-market organizations across the full spectrum of industry verticals.
For contract roles, Genesis10 offers the benefits listed below. If this is a perm-placement opportunity, our recruiter can talk you through the unique benefits offered for that particular client. Benefits of Working with Genesis10: - Access to hundreds of clients, most who have been working with Genesis10 for 5-20 years.
- The opportunity to have a career-home in Genesis10; many of our consultants have been working exclusively with Genesis10 for years.
- Access to an experienced, caring recruiting team (more than 7 years of experience, on average.)
- Behavioral Health Platform
- Medical, Dental, Vision
- Health Savings Account
- Voluntary Hospital Indemnity (Critical Illness & Accident)
- Voluntary Term Life Insurance
- 401K
- Sick Pay (for applicable states/municipalities)
- Commuter Benefits (Dallas, NYC, SF, and Illinois)
For multiple years running, Genesis10 has been recognized as a Top Staffing Firm in the U.S., as a Best Company for Work-Life Balance, as a Best Company for Career Growth, for Diversity, and for Leadership, amongst others. To learn more and to view all our available career opportunities, please visit us at our website.
Genesis10 is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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