GENEWIZ from Azenta Life Sciences · 2 hours ago
Quality Assurance Manager, Software Design & Development
US - Plainfield, IN
Full-time
Onsite
Senior Level
$102K/yr - $127K/yr
5+ years expAzenta Inc. is a company focused on innovation and customer-centric culture. The Quality Assurance Manager for Software Design & Development is responsible for leading and improving the Quality Management System in compliance with ISO 9001, managing quality processes, and ensuring regulatory compliance as the business evolves.
BiotechnologyGeneticsPharmaceutical
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
GENEWIZ from Azenta Life Sciences
GENEWIZ from Azenta Life Sciences is a leading global genomics service provider serving researchers worldwide through a suite of solutions including synthesis, Sanger sequencing, whole plasmid sequencing, and next generation sequencing spanning genomics, transcriptomics, and proteomics.
1001-5000 employees
H1B Sponsorship
GENEWIZ from 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 (3)
2024 (10)
2022 (3)
2021 (17)
2020 (18)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
OrbiMed
2018-09-26Acquired
2015-01-11Series Unknown
Recent News
2025-07-31
Company data provided by crunchbase