Senior Software Quality Engineer for Medical Devices

Werfen; Bedford (MA); On-site; USD 130,000 - 160,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Paid vacation & sick leave

Commission plan

Performance-based bonus

Job summary

Werfen in Bedford, MA is seeking a Senior Software Quality Engineer to ensure product lifecycle compliance with regulatory standards. You will develop and implement methods, tools, and practices across design, development, cybersecurity, verification and validation, and maintenance.

You will lead quality documentation, advise teams on compliance, support audits, and drive process improvements while collaborating with cross‑functional teams on new product development and design changes.

Qualifications

• Bachelor’s degree or equivalent in engineering or science.
• Minimum 8 years of experience in medical devices, pharmaceuticals, diagnostic industry, or clinical laboratory.
• International Mobility Required: No.

Responsibilities

• Generate quality documents throughout the product lifecycle.
• Advise teams on compliance to procedures and standards.
• Ensure product quality meets requirements and documentation is complete.
• Support new product development or design changes.
• Review and approve quality documents throughout the product lifecycle.
• Support audits and corrective actions to maintain compliance.
• Identify compliance gaps and implement corrective actions as needed.
• Lead quality system improvement projects when required.

Skills

Quality standards knowledge

Lean Six Sigma experience

Regulatory/product knowledge

Education

Bachelor’s degree in engineering or science

Job description

Werfen in Bedford, MA is seeking a Senior Software Quality Engineer to ensure product lifecycle compliance with regulatory standards. You will develop and implement methods, tools, and practices across design, development, cybersecurity, verification and validation, and maintenance.

You will lead quality documentation, advise teams on compliance, support audits, and drive process improvements while collaborating with cross‑functional teams on new product development and design changes.