Software Quality Engineer

This is a 6 month contract to FTE position

Must be local to Worecester County, MA

Must be a Green card holder or US Citizen

The Sr. Staff Software Quality Engineer will support the launch and sustaining phases of orthopaedic implants by ensuring the validation, compliance, and ongoing performance of software systems used in additive manufacturing. This role is responsible for leading risk-based software validation and life-cycle activities in accordance with FDA and ensuring compliance with 21 CFR Part 820. The contractor will drive validation of software used for build preparation, machine control, and quality data management, ensuring data integrity, traceability, and reliable execution of validated manufacturing processes.

This position will collaborate closely with engineering, quality, and manufacturing teams to ensure software changes are effectively controlled through release and change management processes without disrupting validated production. The role also includes identifying and mitigating software-related risks, supporting regulatory readiness, and ensuring consistent system performance across a scaled additive manufacturing environment.

• End-to-end software life-cycle processes aligned with FDA are implemented and sustained, ensuring controlled development, verification, and maintenance of all manufacturing-related software.
• Robust software validation strategies are established using a risk-based approach, reducing the likelihood of defects impacting product quality or patient safety while ensuring compliance with 21 CFR Part 820.
• High integrity and traceability of manufacturing and quality data are achieved across systems, supporting device history records, audit readiness, and regulatory submissions.
• Seamless integration between software systems and additive manufacturing processes is ensured, enabling consistent execution of validated build parameters and reducing variability across machines and sites.
• Software-related risks are proactively identified, assessed, and mitigated, with effective controls in place to prevent recurrence of issues impacting implant performance or compliance.
• Efficient change management and software release processes are established, allowing updates and improvements without disrupting validated production or regulatory status.
• Strong cross-functional alignment is achieved between software engineering, quality, and manufacturing teams, accelerating issue resolution and enabling scalable, stable production.
• Continuous monitoring and improvement of software performance and quality systems drive increased reliability, reduced downtime, and sustained compliance throughout the product life cycle.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.