Azenta Life Sciences · 9 hours ago
Quality Assurance Manager, Software Design & Development
Plainfield, IN
Full-time
Onsite
Mid, Senior Level
$102K/yr - $127K/yr
5+ years expAzenta Life Sciences is a company focused on innovation and collaboration in the life sciences sector. They are seeking a Quality Assurance Manager to lead and improve the Quality Management System for software design and development, ensuring compliance with ISO 9001 and integrating quality processes across the organization.
BiotechnologyClinical TrialsLife Science
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
Qualification
Required
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
Preferred
Familiarity with additional standards (e.g., ISO 13485, ISO 27001) is a plus
Company
Azenta Life Sciences
Azenta Life Sciences provides life sciences solutions.
1001-5000 employees
H1B Sponsorship
Azenta Life Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (17)
2024 (3)
2023 (13)
2022 (16)
Funding
Current Stage
Public CompanyTotal Funding
$508.35MKey Investors
JP Morgan ChaseBrooks AutomationBroadOak Capital Partners
2022-11-23Post Ipo Equity· $500M
2021-12-01IPO
2014-03-12Series Unknown· $5.85M
Leadership Team
Lawrence Lin
EVP and CFO
Recent News
2025-12-10
Morningstar.com
2025-11-21
Company data provided by crunchbase