Compliance Specialist III
System One, San Antonio, TX, United States
Job Title: Compliance Specialist III
Location: Sunnyvale, California
Type: 6 month contract
Compensation: $25/HOUR
Contractor Work Model: Onsite
Hours: 40.0
Overview
This role supports quality and regulatory compliance activities within a medical device manufacturing environment. The Compliance Specialist III ensures adherence to internal procedures and external standards, including FDA and global quality regulations. This position is suited for a detail‑oriented professional experienced in compliance documentation, audits, and quality systems.
Responsibilities
Support quality management system (QMS) activities, including document control, training records, and audit readiness
Assist with internal and external audits (e.g., FDA, ISO), including preparation, documentation, and follow‑up actions
Review, update, and maintain SOPs, work instructions, and compliance documentation
Track and manage CAPA, deviations, and non‑conformance records to ensure timely resolution
Ensure compliance with applicable regulations, including FDA 21 CFR Part 820 and ISO 13485
Collaborate with Quality, Regulatory, and Manufacturing teams to maintain alignment on compliance initiatives
Maintain accurate records and contribute to compliance reporting and metrics tracking
Coordinate training activities and monitor compliance with training requirements
Requirements
Bachelor’s degree in Life Sciences, Engineering, or a related field, or equivalent practical experience
1–3 years of experience in compliance, quality, or regulatory support within a regulated industry (medical device, pharmaceutical, or biotech)
Working knowledge of FDA regulations (21 CFR Part 820) and/or ISO 13485
Experience with QMS systems, document control processes, and audit support
Familiarity with CAPA, deviation management, and non‑conformance processes
Proficiency in Microsoft Office applications (Excel, Word, Outlook)
Strong attention to detail with the ability to manage and maintain accurate documentation
System One offers eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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Location: Sunnyvale, California
Type: 6 month contract
Compensation: $25/HOUR
Contractor Work Model: Onsite
Hours: 40.0
Overview
This role supports quality and regulatory compliance activities within a medical device manufacturing environment. The Compliance Specialist III ensures adherence to internal procedures and external standards, including FDA and global quality regulations. This position is suited for a detail‑oriented professional experienced in compliance documentation, audits, and quality systems.
Responsibilities
Support quality management system (QMS) activities, including document control, training records, and audit readiness
Assist with internal and external audits (e.g., FDA, ISO), including preparation, documentation, and follow‑up actions
Review, update, and maintain SOPs, work instructions, and compliance documentation
Track and manage CAPA, deviations, and non‑conformance records to ensure timely resolution
Ensure compliance with applicable regulations, including FDA 21 CFR Part 820 and ISO 13485
Collaborate with Quality, Regulatory, and Manufacturing teams to maintain alignment on compliance initiatives
Maintain accurate records and contribute to compliance reporting and metrics tracking
Coordinate training activities and monitor compliance with training requirements
Requirements
Bachelor’s degree in Life Sciences, Engineering, or a related field, or equivalent practical experience
1–3 years of experience in compliance, quality, or regulatory support within a regulated industry (medical device, pharmaceutical, or biotech)
Working knowledge of FDA regulations (21 CFR Part 820) and/or ISO 13485
Experience with QMS systems, document control processes, and audit support
Familiarity with CAPA, deviation management, and non‑conformance processes
Proficiency in Microsoft Office applications (Excel, Word, Outlook)
Strong attention to detail with the ability to manage and maintain accurate documentation
System One offers eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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