Quality Assurance Manager, Software Design & Development

Location: US - Plainfield, IN

Time Type: Full time

Job Description

At Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships.

All we accomplish is grounded in our core values of Customer Focus, Achievement, Accountability, Teamwork, Employee Value and Integrity

Job Description

At Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer-focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships.

Azenta Life Sciences is a global leader in the life sciences space. We are a market leader in automated bio sample management solutions and genomic services across areas such as drug development, clinical and advanced cell therapies for the industry's top pharmaceutical, biotech, academic and healthcare institutions globally. Our Springfield, MO facility performs manufacturing operations for biological storage units.

How You’ll Add Value:

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.

What You’ll Do:

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.

Your Management Responsibilities:

Collaboration

• Constructive conflict

• Appropriate follow-up

• Holds self and other accountable

• Builds relationships & partners across-functions

• Considers and communicates cross-functionally

Communication to Inspire & Empower

• Regular meaningful communications

• Connection of department & individual purpose to strategic direction

• Follow-up to address obstacles

What You Will Bring:

• 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

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

Your Working Conditions: 

• Typical office environment Occasional travel to support audits, integration activities, or cross-site collaboration

• Employee may be working on an area with potentially infectious materials

• Employee will be responsible for maintaining a clean work environment and enforce and follow universal precautions for bloodborne pathogens when working in an area considered to be potentially contaminated

Join us and help enable life‑changing discoveries by keeping critical life science systems running reliably—every day.

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If any applicant is unable to complete an application or respond to a job opening because of a disability, please email at [email protected] for assistance. 

Azenta is an Equal Opportunity Employer. This company considers candidates regardless of race, color, age, religion, gender, sexual orientation, gender identity, national origin, disability or veteran status.

The posted pay range for this position is an estimate based on current market data and internal pay structure. Final compensation may vary above or below this range depending on factors such as experience, education (including licensure and certifications),  qualifications, performance, and geographic location, among other relevant business or organizational needs.