Quality Assurance Manager, Software Design & Development

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

How Youll 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 Youll 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

• Bachelors 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.

If any applicant is unable to complete an application or respond to a job opening because of a disability please email at 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.