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AVANOS · 1 day ago

Manager, Quality Assurance (6873)

Full-time

Onsite

Mid, Senior Level

5+ years exp

Avanos Medical is a medical device company focused on delivering clinically superior breakthrough solutions. The Manager, Quality Assurance is responsible for overseeing the Quality Management System (QMS) and ensuring product quality compliance with customer requirements while supporting operational expansion.

Electrical & Electronic Manufacturing

Responsibilities

Maintain, oversee, and continually improve the ISO 13485–compliant and FDA QSMR/QSR–compliant QMS

Develop, revise, and implement QMS procedures, work instructions, and controlled documents

Ensure QMS performance and control during operational expansion (e.g., going from one shift to two, increasing employees per shift), including process standardization, training, communication, and consistency of product quality across shifts

Incumbent reports to the Senior Director Quality Operations & Sustaining Engineering

Ensure product quality for sterile disposable medical products, including in-process inspections, final inspections, packaging operations, sterilization and environmental controls

Monitor and analyze quality trends across all shifts; drive investigations and corrective actions for nonconformances, scrap, and process deviations

Partner with Operations and Engineering to support validation and re-validation activities (IQ/OQ/PQ) and continuous improvement projects

Lead and direct sterilization compliance and performance, including revalidation activities, routine cycle conformity, LAL/bioburden monitoring programs, and cross-functional coordination with operations, laboratories, and suppliers to ensure continued sterility assurance and regulatory compliance

Lead and direct cross-functional evaluation of process and design changes, ensuring appropriate risk assessments, regulatory impact reviews, and validation/verification activities are completed

Ensure change controls maintain compliance with FDA QSR/QSMR, ISO 13485, and product requirements without disrupting product quality, safety, or availability

Lead and direct employee training programs, ensuring timely onboarding, competency verification, and documented training compliance across all departments and shifts

Lead and direct complaint handling, MDR evaluation support, and post-market surveillance activities, including trend reporting and closure within defined timelines

Own the CAPA system, ensuring thorough root-cause analysis, appropriate corrective actions, trend monitoring, and verification of effectiveness

Represent the company during ISO audits, FDA inspections and customer audits

Support and/or lead regulatory submissions (e.g., 510(k), letters to file) as needed

Monitor and communicate changes to applicable regulations, standards, and guidance

Lead and direct supplier qualification, auditing, SCARs, performance monitoring, and quality agreements

Ensure incoming inspection effectiveness, risk-based supplier controls, and component traceability

Establish and track site quality metrics, objectives, and dashboards aligned to company goals

Prepare and present QMS performance and quality data during Management Reviews

Lead and develop Quality Technicians, Inspectors, and support roles across multiple shifts

Serve as the site Management Representative for QMS compliance

Qualification

ISO 13485FDA QSRQuality Management SystemCAPA ManagementRegulatory ComplianceProcess ImprovementSupplier Quality ManagementComplaint HandlingTeam LeadershipCommunication Skills

Required

Minimum 5–7 years in a regulated manufacturing industry (medical device, pharma, biotech, or similar)

Bachelor's degree in engineering, Quality, Life Sciences, or related field

Hands-on experience maintaining product quality and QMS performance while expanding a manufacturing operation from one shift to two (or similar multi-shift expansion)

Deep knowledge of FDA QSR/QSMR, ISO 13485, and medical-device quality principles

Proven experience managing audits (FDA, ISO, customers) and regulatory compliance activities

Strong background in complaint handling, CAPA, nonconformance management, and quality metrics

Experience supporting or managing validations (IQ/OQ/PQ)

Demonstrated ability to lead and develop quality teams

Excellent written and verbal communication skills