Senior Compliance Analyst at Pomeroy

Portage, Michigan, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Feb, 26

Salary

0.0

Posted On

04 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Document Control, Training Management, Audit Readiness, Nonconformance, Corrective Actions, Preventive Actions, ISO Standards, NIST Framework, Generative AI, Prompt Engineering, Root Cause Analysis, Quality Management, Attention to Detail, Communication Skills, Organizational Skills, Customer Focus

Industry

IT Services and IT Consulting

Description

Position Summary: We are seeking a proactive and detail-oriented Compliance Analyst to support the integrity, quality, and effectiveness of our compliance programs. The ideal candidate will have experience in one or more of the following areas: document control, training management, audit readiness, or nonconformance (NC)/corrective and preventive actions (CAPA), with a working knowledge of regulatory frameworks such as ISO 13485, ISO 9001, ISO 27001, and NIST. While the core of this role is operational compliance and quality system support, we also value candidates with emerging skills in prompt engineering—leveraging generative AI to improve content quality, knowledge access, and documentation workflows. This role offers a unique blend of traditional compliance responsibilities with the opportunity to shape how emerging AI tools can support quality and regulatory functions. If you are equally comfortable with version control and root cause analysis as you are experimenting with LLM prompts and AI writing assistants, this is the role for you. Essential duties & responsibilities: (detailed description) Document Control & Quality Systems · Manage the creation, revision, and approval of controlled documents using an electronic document management system. · Ensure documentation complies with internal style guidelines and external regulations such as ISO 9001 (or ISO 13485), ISO 20000, and ISO 27001. · Review new/revised documents to assess impact on other Quality Management System documentation and ensure compliance with established procedure. · Coordinate and monitor processes such as periodic review and corporate notifications to assess potential impact of new/changed Corporate documents. Training Compliance · Administer training assignments related to controlled documents using a Learning Management System (LMS) such as ComplianceWire or Cornerstone. · Monitor completion status, report on compliance metrics, and support periodic reviews of training effectiveness. Nonconformance and CAPA Support · Assist with the intake, documentation, investigation, and resolution of NCs and CAPAs, ensuring timeliness and data integrity. · Participate in root cause analysis and effectiveness checks. Compliance and Audit Support · Prepare documentation and evidence for internal and external audits. · Support audit response, remediation plans, and follow-up actions. · Track and trend compliance KPIs and escalate risks appropriately. Preferred: Prompt Engineering & AI Enablement · Use generative AI tools (e.g., ChatGPT, Claude, Copilot) to assist in optimizing quality processes. · Create and test prompt templates. · Collaborate on AI pilot projects that enhance quality and productivity. Education & special trainings: · Bachelor's Degree from an accredited university required. · Bachelor's Degree in Information Systems, Quality Management, Regulatory Affairs, Technical Writing or similar technical degree preferred. Qualifications & experience: Required: · 2+ years of experience in compliance, quality systems, or document control within a regulated industry. · Demonstrated hands-on experience with document control and training systems (e.g., Windchill, ComplianceWire, SharePoint). · Familiarity with ISO and regulatory standards including ISO 9001/13485, ISO 20000, ISO 27001, or NIST frameworks. · Excellent attention to detail, organizational, and communication skills. · English as a first language. Preferred: · Experience supporting internal or external audits. · Familiarity with NC/CAPA systems and quality event documentation. · Working knowledge of prompt engineering or generative AI tools in a compliance or documentation context. · Certifications in Quality (e.g., CAPA Certified, ISO 13485 Auditor) or AI (e.g., Prompt Engineering, AI Fundamentals). Physical & mental requirements: · Excellent communication skills. Must effectively communicate cross-functionally and at a variety of levels within the organization. · Approachability, Composure, and Interpersonal Savvy. Must be approachable and relate well to a variety of personalities. Must be able to build appropriate rapport; build constructive and effective relationships; use diplomacy and tact to drive adherence to established procedure; remain cool under pressure and/or when dealing with stressful situations. · Critical Thinking and Decision Quality. Must have the ability to make sound decisions and provide practical advice on compliance issues based upon a mixture of analysis, wisdom, experience and judgement. · Strong Customer Focus. Must have strong customer focus to enable the IT organization to meet processing and publication timelines for critical documentation and/or initiatives. #LI-DNI

Responsibilities

The Senior Compliance Analyst will manage document control and quality systems, ensuring compliance with internal and external regulations. The role also involves supporting training compliance, nonconformance, CAPA processes, and audit preparations.