Job Title: Sr. Software Quality Engineer
Work Location: Worcester County, Massachusetts
Summary:
The Sr. Software Quality Engineer is responsible for ensuring the validation, compliance, and ongoing performance of software systemss. This role leads risk-based software validation and lifecycle activities in accordance with FDA regulations, focusing on data integrity, traceability, and reliable execution of validated manufacturing processes. The position collaborates with engineering, quality, and manufacturing teams to control software changes, mitigate risks, and support regulatory readiness, ensuring consistent system performance across a scaled manufacturing environment.
Responsibilities:
- Lead validation and release of software systems, including build preparation, machine control, and quality data management, to enable compliant and efficient product launches.
- Implement and sustain end-to-end software lifecycle processes aligned with FDA requirements, ensuring controlled development, verification, and maintenance of manufacturing-related software.
- Develop and execute robust, risk-based software validation strategies to minimize defects and ensure compliance with 21 CFR Part 820.
- Ensure high integrity and traceability of manufacturing and quality data across systems to support device history records, audit readiness, and regulatory submissions.
- Facilitate seamless integration between software systems and additive manufacturing processes, ensuring consistent execution of validated build parameters and reducing variability.
- Proactively identify, assess, and mitigate software-related risks, implementing effective controls to prevent recurrence of issues impacting product performance or compliance.
- Establish efficient change management and software release processes to allow updates and improvements without disrupting validated production or regulatory status.
- Drive strong cross-functional collaboration between software engineering, quality, and manufacturing teams to accelerate issue resolution and enable scalable, stable production.
Qualifications:
- Bachelor’s degree in Engineering, Computer Science, or a related technical field; advanced degree preferred.
- Extensive experience in software quality engineering, validation, or compliance within a regulated manufacturing or medical device environment.
- Strong knowledge of FDA regulations, including 21 CFR Part 820, and experience with risk-based software validation methodologies.
- Demonstrated ability to manage software lifecycle processes, change management, and release controls in a manufacturing context.
- Experience with additive manufacturing, 3D printing technologies, or related software systems is highly desirable.
- Proven track record of cross-functional collaboration with engineering, quality, and manufacturing teams.
- Excellent problem-solving, communication, and project management skills.
- Ability to support regulatory audits and submissions through robust documentation and data integrity practices.
Published Category: Quality & Validation, Technology & Data & AI Solutions
