Senior Quality Engineer, Medical Device Software (SaMD)

Johnson & Johnson Innovative Medicine; Boston (MA); Vor Ort; USD 109.000 - 175.000; Vollzeit

Zusammenfassung

Johnson & Johnson Innovative Medicine is seeking a Senior Quality Engineer to lead quality efforts on medical device software development. You will oversee requirements, risk assessments, test strategies, and design controls while guiding project teams through regulatory compliance.

In this role, you will support regulatory filings, investigations of CAPAs, and audits, mentoring junior staff and ensuring protection of patient data. A strong background in IEC 62304 and ISO 13485 is expected.

Qualifikationen

• Bachelor’s degree required; advanced degree preferred.
• Minimum 4 years in quality, new product development, or manufacturing engineering in a regulated industry.

Aufgaben

• Lead quality activities on medical device software development projects.
• Provide guidance on software risk assessments and design controls.
• Support regulatory filings and inspections; manage CAPAs and non-conformances.

Kenntnisse

Software quality

Regulated industry

Quality tools

Team collaboration

Communications

Ausbildung

Bachelor's degree

Advanced degree preferred

Tools

ASQ Certification

Jobbeschreibung

Johnson & Johnson Innovative Medicine is seeking a Senior Quality Engineer to lead quality efforts on medical device software development. You will oversee requirements, risk assessments, test strategies, and design controls while guiding project teams through regulatory compliance.

In this role, you will support regulatory filings, investigations of CAPAs, and audits, mentoring junior staff and ensuring protection of patient data. A strong background in IEC 62304 and ISO 13485 is expected.