Compliance Specialist III

Field Action Quality Specialist

We are seeking a Field Action Quality Specialist to support product recall and field action activities within a regulated environment. This role serves as a key liaison between customers, quality teams, regulatory functions, and cross-functional stakeholders to ensure timely processing, documentation, reporting, and communication related to field actions. The ideal candidate combines regulatory knowledge, strong organizational skills, and a customer-focused approach to support compliance and audit readiness objectives.

Responsibilities include:

• Process, reconcile, and maintain customer acknowledgment forms in accordance with regulatory requirements and internal procedures.
• Serve as a point of contact for customer inquiries related to product recalls and field actions.
• Monitor and report field action effectiveness metrics and support ongoing effectiveness assessments.
• Assist in preparing monthly regulatory reports and status updates related to field action activities.
• Communicate field action progress, risks, and key updates to cross-functional teams and stakeholders.
• Support audit readiness efforts by maintaining accurate documentation and providing information required for internal and external audits.
• Manage and prioritize field action and recall-related communications, ensuring urgent matters are addressed appropriately.
• Perform assessments, develop action plans, and support execution of activities to improve field action processes and effectiveness.
• Collaborate with quality, regulatory, and business partners to maintain and enhance quality system procedures and processes.
• Support document retention and records management activities in accordance with company policies and regulatory requirements.
• Assist with escalation management and resolution of customer concerns related to field actions and product recalls.

Required Qualifications

• Bachelor's degree in Engineering, Physical Sciences, Biological Sciences, or another technical discipline.
• Minimum of 4 years of experience in product quality, regulatory compliance, or a combination of related experience within a regulated industry.
• Experience supporting product recalls, field actions, quality systems, or regulatory compliance activities.
• Working knowledge of U.S. medical device regulations, including 21 CFR Part 820 and 21 CFR Part 11.
• Familiarity with international quality and regulatory standards, including ISO 13485 and ISO 14971.
• Strong organizational, written, and verbal communication skills.
• Strong analytical, critical thinking, and problem-solving abilities.
• Ability to manage multiple priorities and deadlines in a fast-paced environment.
• Experience collaborating across cross-functional teams and managing stakeholder relationships.
• Proficiency with standard business software and electronic documentation systems.

Preferred Qualifications

• Experience within the medical device industry.
• Familiarity with international regulatory requirements, including Canada, European Union, and Brazil regulations.
• Experience with computer system regulations, validation standards, or related methodologies.
• Experience interacting directly with regulatory agencies, including the FDA, Notified Bodies, or other governmental authorities.
• Experience supporting internal and external audits.
• Knowledge of quality management systems and continuous improvement methodologies.
• Experience managing customer communications related to quality, compliance, or field action activities.

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.