Senior Software Quality Engineer

Gener8 | The RND Group; Indiana (PA); On-site; USD 110,000 - 165,000; Full time

Benefits offered by this job

Bonuses

Comprehensive benefits

Job summary

Gener8 | The RND Group is seeking a Senior Quality Systems Engineer to maintain and improve a FDA‑regulated QMS and ensure compliance with QSR, ISO 13485, IEC 62304, and ISO 14971. You will assess DHFs and client QMS with recommendations and drive quality improvements.

Responsibilities include leading assessment projects, authoring procedures, and training teams on software lifecycle processes, with occasional travel to client sites.

Qualifications

• Bachelor’s degree in a relevant field is required.
• Strong knowledge of FDA QSR, ISO 13485, IEC 62304, ISO 14971.
• Experience in software quality engineering in medical devices.
• Ability to write procedures, policies and templates.
• Ability to perform audits and support design history files.

Responsibilities

• Lead assessment projects for client QMS and DHFs.
• Assess client QMS documents and SDLC processes for compliance.
• Provide and implement recommendations to address findings.
• Author and update procedures and templates.
• Support internal product development teams on software lifecycle.
• Develop and conduct training on software lifecycle processes.
• Ensure QMS and SDLC meet quality and regulatory requirements.
• Identify opportunities to improve quality system processes.
• Perform or facilitate internal audits and CAPA management.
• Travel as required.

Skills

Communication skills

Fast-paced environment

Team player

Independence in work

Quality/regulatory knowledge

SDLC knowledge

Audits experience

Procedures and templates

Regulatory standards familiarity

Regulatory certifications

Education

Bachelor’s degree in Computer Science, Software Engineering, Bioinformatics, Biomedical or related discipline

Job description

Overview

RND develops software to assist with our clients’ next generation medical device platforms and instruments. These platforms and instruments provide “breakthrough” technologies that are used to diagnose cancer and other diseases, develop personalized medicines, provide gene sequencing, and perform research to assist with developing other healthcare solutions. Based on our expertise in developing medical device software, we provide assessments and remediation of our clients’ quality management systems, software development life cycle processes, design history files, and other software-related deliverables.

Job Description

The successful candidate will have experience working within quality management systems that are compliant with FDA’s Quality System Regulation, ISO 13485, ISO 14971, and IEC 62304. The Senior Quality Systems Engineer will be responsible for maintaining, supporting, and improving RND’s Quality Management System (QMS) and ensuring its compliance with applicable regulations, standards, and guidance documents. The Senior Quality Systems Engineer will also perform assessments of client QMS documents and Design History Files (DHFs) to determine compliance with applicable regulations, standards, and guidance documents, as well as provide and execute recommendations to address findings.

Required Skills And Qualifications

• Bachelor’s degree in Computer Science, Software Engineering, Bioinformatics, Biomedical or related discipline
• Quality and/or Regulatory Certifications (ASQ, RAC, etc.)
• 8 years’ experience working in (software) quality engineering or related role in a medical device company
• Strong understanding of and experience with FDA’s QSR, ISO 13485, IEC 62304, and ISO 14971
• Working knowledge of product development, and specifically software development lifecycle (SDLC) processes, software engineering best practices
• Experience with internal and/or supplier audits
• Experience writing procedures, policies, and templates
• Able to deliver quality output under little supervision and with general direction
• Ability to operate flexibly in a fast-paced environment
• Excellent oral and written communication skills
• Demonstration of ability to work on a team

Tasks And Responsibilities

RND Group offers competitive pay, bonuses, and comprehensive benefits.

• Lead assessment projects
• Perform assessments of client QMS documents, especially software development lifecycle processes
• Provide recommendations to address assessment findings
• Author new procedures and templates
• Update existing procedures and templates
• Provide quality support to internal product development teams focusing on software lifecycle processes within design control
• Develop and conduct training on software lifecycle processes to internal project teams and clients
• Ensure QMS and SDLC processes meet quality and regulatory requirements
• Identify areas and opportunities to improve quality system processes
• Perform or facilitate non-SDLC activities in the QMS, like internal audits, CAPA management
• Additional tasks under Quality Assurance and Compliance as directed
• Occasional travel may be required

About RND

RND is a highly specialized software engineering firm dedicated to the FDA regulated medical device market. We work with companies by partnering with their product development organizations in providing quality management consultation and services, and full-lifecycle software services as needed to complement our clients’ existing engineering departments.

Gener8 | The RND Group
5975 Castle Creek Pkwy N Dr, Ste 250
Indianapolis, IN 46250
317-841-8070