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Compliance Specialist III

System One • Sunnyvale, CA • 6h ago

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, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer 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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Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time 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.

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