Manager, Quality Systems - CAPA Inspection Management

Job description

Overview

Job Summary

The Manager, Quality Systems - CAPA & Inspection Management leads the Norcross site end-to-end qual-ity event/CAPA governance and inspection-management processes within Quality Systems & Compliance. The role provides management oversight of Quality System personnel responsible for event/CAPA review and approval and establishes consistent governance from Phase 1 event definition (EDF) through Phase 2 root cause investigation (RCI), corrective/preventive action, effectiveness verification, and closure. The Manager also leads site Quality System oversight through quality metrics, Quality System Management Review (QSMR), internal and external audit readiness, and regulatory/notified-body inspection manage‑ment. This role partners across Quality and Operations to ensure issues are risk-assessed, investigated to appropriate depth, actions are sustainable and effective, systemic trends are identified, and the site main‑tains a state of inspection readiness.

Responsibilities

Key Accountabilities

Lead, coach, mentor, and develop Quality Systems personnel responsible for event/CAPA review and approval, inspection readiness, audit support, and assigned Quality System activities; establish stand‑ard work, workload priorities, backup coverage, and performance expectations.

Lead day-to-day governance of the end-to-end Event/CAPA process, including Phase 1 Event Definition (EDF), Phase 2 Root Cause Investigation (RCI), corrective/preventive action planning, implemen‑tion, effectiveness verification, and closure.

Establish and maintain clear, risk‑based standards and approval criteria for event classification, prob‑lem definition, investigation depth, root cause determination, CAPA adequacy, due‑date management, extensions, and effectiveness checks.

Ensure Quality System approvers provide independent, timely, consistent, and compliant review and approval of events, investigations, CAPAs, extensions, and effectiveness evidence.

Monitor Event/CAPA performance through meaningful metrics, including aging, overdue records, cycle time, recurrence, right‑first‑time approval, extensions, and effectiveness failures; identify sys‑temic trends and elevate significant compliance risk.

Lead site inspection management and readiness, including inspection plans, front‑room/back‑room coordination, SME preparation, request tracking, response governance, observation management, mock inspections, and post‑inspection follow‑up.

Plan and coordinate internal audits and support regulatory/notified‑body and customer inspections in partnership with process owners and applicable Corporate/Global Quality functions; ensure resulting commitments are governed, completed on time, and evaluated for effectiveness.

Own or coordinate Quality System performance metrics and QSMR inputs, ensuring data are accurate, risk‑based, appropriately trended, and translated into clear management actions and follow‑up.

Partner with Manufacturing QA, Laboratory Services, Post‑Market Surveillance, Design & Sustaining Quality Engineering, Regulatory Affairs, Manufacturing, Supply Chain, and other process owners to ensure Quality events, CAPAs, audits, and inspection commitments are appropriately owned and re‑solved.

Provide Quality System expertise and interpretation of applicable FDA, ISO 13485, MDSAP, EU IVDR, and internal Quality requirements while fostering patient safety, compliance, right‑first‑time execution, transparency, accountability, and continuous improvement.

Performs other duties and responsibilities as assigned

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key relationships

Network with Quality Systems & Compliance, Manufacturing Quality Assurance, Laboratory Services, Post‑Market Surveillance, Design & Sustaining Quality Engineering, Regulatory Affairs, Manufacturing, Engineering, Supply Chain, site leadership, Corporate Quality, and other applicable organizations to ensure effective CAPA governance and inspection readiness.

Qualifications

Minimum Knowledge & Experience required for the position:

Bachelor’s degree (BS/BA) from four‑year college or university; or equivalent combination of education and experience.

Four‑year scientific/technical degree or 5 plus years of experience in a comparable manufacturing environment is required to ensure sound judgment and performance, preferred

Experience/certification as a medical technologist is preferred

Skills & Capabilities:

Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, and government regulations.

Ability to write reports, business correspondences and procedures manuals.

Travel requirements: If required, provide approximate percentage of travelling time.

Closing

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

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Worksite address

norcross, GA, 30092, US

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.