Senior Medical Device QMS 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

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.