Quality Assurance Manager, Software Design & Development

Azenta Life Sciences•Plainfield, IN

About The Position

The Quality Manager – Software Design & Development is responsible for leading, maintaining, and continuously improving the Quality Management System (QMS) for the software design and development portion of the business in accordance with ISO 9001. This role has end-to-end ownership of quality system processes for the assigned business segment and plays a key role in integrating those processes with other internal quality systems across the organization. The position requires strong expertise in software design and development controls, risk-based quality management, cross-functional collaboration, and change management to ensure alignment, scalability, and regulatory compliance as the business grows.

Requirements

Bachelor’s Degree
5+ years of progressive experience in Quality Management within a regulated or ISO-certified environment.
Demonstrated experience managing design and development quality processes for software.
Hands-on experience implementing, maintaining, or improving an ISO 9001-compliant QMS.
Experience integrating or harmonizing quality systems across multiple business units or organizations.
ISO 9001 Lead Auditor certification or equivalent
Experience with SaaS, cloud-based, or enterprise software environments.

Nice To Haves

Familiarity with additional standards (e.g., ISO 13485, ISO 27001) is a plus

Responsibilities

Own and manage the QMS for the software design and development scope of the business in compliance with ISO 9001 requirements.
Establish, maintain, and improve quality policies, procedures, SOPs, and records related to software lifecycle activities.
Ensure QMS processes are effectively implemented, maintained, and monitored for performance and effectiveness.
Schedules, facilitates, and responds to client audits.
Develops relationships with targeted clients.
Conducts regular internal audits to ensure compliance to QMS.
Manage complaints, nonconformance and CAPA activities related to software quality processes.
Monitor quality metrics and trends to identify risks and improvement opportunities.
Drives continuous improvement activities based on data from quality measuring and monitoring activities such as audit findings, customer feedback, deviations, non-conformance, etc.
Ensure design and development processes are defined, documented, and executed in compliance with ISO 9001 requirements.
Oversee design planning, design inputs and outputs, design reviews, verification, validation, and design changes for software products and provide quality oversight, as applicable.
Ensure appropriate risk management practices are applied throughout the software development lifecycle.
Partner closely with Software Engineering, Product Management, IT, QA, and Operations teams.
Provide quality guidance and decision-making support during product development, changes, and releases.