Compliance Specialist III

System One; Sunnyvale (CA); Hybrid; USD 97,424,000 - 106,681,000; Full time

Benefits offered by this job

Health and welfare benefits

401(k) plan

Job summary

System One is seeking an Audit Compliance Associate in Sunnyvale, CA for a contract role. The position offers a hybrid work model (onsite and remote) with a 40-hour week.

Responsibilities include coordinating external audits, tracking findings, generating metrics, and ensuring timely governance reviews. The role requires 2–3 years in medical device compliance and a Bachelor's or technical degree.

Qualifications

• Minimum Bachelor's Degree or equivalent years of experience in engineering, physical or biological science or other technical field.
• A minimum of 2-3 years of experience in compliance role in the medical device industry.
• Working knowledge of project management tools and techniques.
• Knowledge of EU-MDR, ISO 13485:2016; Medical Device Single Audit (MDSAP), and 21 CFR 820 requirements, Health Canada, and other international regulatory requirements.
• Certified Quality Auditor/ISO lead Auditor Certification desired.
• Demonstrated ability to effectively work with cross-functional/cross-plant project teams and with a variety of work groups.
• Experience interpreting and providing guidance on domestic and international regulations as applicable to the quality management system.
• Strong organizational, written and verbal communication skills and the proven ability to prioritize tasks effectively in a deadline-driven environment.
• Strong interpersonal skills - ability to work closely with people at all levels within the organization and facilitate the implementation of corrective action.

Responsibilities

• Manage external audit administration activities, including coordination, logistics, and preparation for external audits.
• Monitor the audit finding related activities to ensure timely completion.
• Develop and facilitate reporting of audit metrics to ensure compliance to procedures and commitments.
• Execute governance processes for timely reviews of audit findings and visibility to Senior Management.
• Promote a culture of compliance to regulations, standards, and procedures and risk management.
• Serve as liaison for engineering change orders/QMS project support.
• Lead and refine the internal audit module and provide training as needed.
• Monitor and audit adherence to corporate policies and coordinate investigations.
• Lead other audit management related projects as required.

Skills

Regulatory compliance

Quality auditing

Cross-functional collaboration

Communication skills

Regulatory interpretation

Risk management

Education

Bachelor's degree

Engineering/Technical degree

Tools

Project management tools

Job description

Job Title: Audit Compliance Associate
Location: Sunnyvale, CA
Type: Contract
Compensation: $34 - $37.25/hr
Work Model: Hybrid – onsite and remote
Hours: 40.0

Overview

Audit Compliance Associate performs the day-to-day administration of all processes related to internal and external audit. This role ensures that all Quality audit activities are being performed per Intuitive Surgical released procedures.

Responsibilities

• Manage external audit administration activities, including coordination, logistics, and preparation for external audits
• Monitor the audit finding related activities as a result of internal and external audits to ensure timely completion
• Develop and facilitate the reporting of external and internal audit related metrics to ensure compliance to internal procedure and external commitments
• Execute the governance process to ensure timely and effective reviews of audit findings and visibility to Senior Management
• Promote a culture of compliance to regulations, standards, and procedures and risk management through monitoring and reporting process
• Serve as key liaison for engineering change orders/QMS project support
• Lead and refine the internal audit module, including troubleshooting issues as needed and knowing when to elevate to IT, partnering with Training LMS Administrator to develop, improve, and administer Audit Module training, provide group or individual training, ensure process changes per documented procedures in Audit Module
• Monitor and audit adherence to corporate policies as directed and investigate any violations, including coordinating investigations, audits, conducting interviews, and preparing reports
• Lead other audit management related projects as required

Requirements

• Minimum Bachelor's Degree or equivalent years of experience, in Engineering, physical or biological science or other technical field
• A minimum of 2-3 years of experience in compliance role in the medical device industry
• A working knowledge of project management tools and techniques
• Knowledge of EU-MDR, ISO 13485:2016; Medical Device Single Audit (MDSAP), and 21 CFR 820 requirements, Health Canada, and other international regulatory requirements
• Certified Quality Auditor/ISO lead Auditor Certification desired
• Demonstrated ability to effectively work with cross-functional/cross-plant project teams and work effectively with a variety of work groups
• Experience interpreting, and providing guidance on domestic and international regulations as applicable to the quality management system
• Strong organizational, written and verbal communication skills and the proven ability to prioritize tasks effectively in a deadline-driven environment
• Strong interpersonal skills - ability to work closely with people at all levels within the organization and facilitate the implementation of corrective action

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.