Senior Software Quality Engineer - Risk and Compliance Lead

Socket.dev; Bedford (MA); On-site; USD 130,000 - 160,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with employer match

Paid vacation

Paid sick leave

Bonus eligibility

Job summary

Werfen is seeking a Senior Software Quality Engineer to ensure product lifecycle compliance with applicable standards and regulations. You will develop, apply and implement methods for design, development, cybersecurity, verification and validation.

You will work with cross-functional teams to drive quality improvements, risk management and audits, while promoting lean process improvements and robust documentation across medical devices and diagnostics.

Qualifications

• Bachelor’s degree in engineering or science.
• Minimum 8 years of experience in medical devices, pharmaceuticals, diagnostic industry, or clinical laboratory (5 years if degree substituted).
• International mobility not required; travel ~10%.

Responsibilities

• Generates and reviews quality documents throughout the product lifecycle.
• Advises teams on regulatory procedures and updates procedures as regulations evolve.
• Ensures product quality meets requirements and documentation is complete before approval.
• Participates in new product development and design change support on core teams.
• Reviews and approves quality documents across the lifecycle and supports audits.
• Identifies compliance gaps and implements corrective actions; leads quality-improvement projects.
• Collaborates with cross-functional teams to communicate quality requirements and drive continuous improvement.
• Performs other duties as assigned.

Skills

Quality standards

Lean Six Sigma

Regulatory risk

Statistics

Product lifecycle

Education

Bachelor’s degree in engineering or science

Tools

Quality Management System (QMS)

Job description

Werfen is seeking a Senior Software Quality Engineer to ensure product lifecycle compliance with applicable standards and regulations. You will develop, apply and implement methods for design, development, cybersecurity, verification and validation.

You will work with cross-functional teams to drive quality improvements, risk management and audits, while promoting lean process improvements and robust documentation across medical devices and diagnostics.