Senior Software Quality Engineer Med Devices Cybersecurity

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

Benefits offered by this job

Medical, dental, and vision insurance

401k plan retirement benefits

Paid vacation and sick leave

Job summary

A global diagnostic solutions company in Massachusetts is seeking a Senior Software Quality Engineer responsible for ensuring product lifecycle compliance with applicable standards. The ideal candidate will have over 8 years of experience in the medical devices or diagnostic industry, demonstrating strong skills in quality management techniques and regulatory compliance. This role offers a competitive salary range of $130K - $160K, along with benefits such as medical insurance, 401k, and paid leave.

Qualifications

• Minimum 8 years of experience in medical devices or related fields.
• Ability to negotiate and influence for improved quality.
• Demonstrated understanding of risk-based approach.

Responsibilities

• Ensure product lifecycle compliance with standards.
• Generate quality documents throughout the product lifecycle.
• Review and approve quality documents.

Skills

Quality management techniques (Lean, Six Sigma)

Statistical techniques

Knowledge of domestic and international quality/regulatory standards

Effective communication

Judgment for regulatory compliance

Education

Bachelor’s degree or equivalent in engineering or science

Job description

A global diagnostic solutions company in Massachusetts is seeking a Senior Software Quality Engineer responsible for ensuring product lifecycle compliance with applicable standards. The ideal candidate will have over 8 years of experience in the medical devices or diagnostic industry, demonstrating strong skills in quality management techniques and regulatory compliance. This role offers a competitive salary range of $130K - $160K, along with benefits such as medical insurance, 401k, and paid leave.