Senior Software Quality Engineer: Drive Compliance

Werfenlife SA.; Bedford, Northern (MA, KY); Hybrid; USD 130,000 - 160,000; Full time

Benefits offered by this job

Medical insurance

401(k) retirement plan

Paid time off

Bonus program

Commission plan

Job summary

Werfen is seeking a Senior Software Quality Engineer in Bedford, MA, to ensure lifecycle compliance, develop and apply methods, and support design, development, cybersecurity, verification and validation.

The role requires advanced analytical skills, risk management, and collaboration with project teams to achieve quality goals. We offer medical/dental/vision, 401k with employer match, paid time off, and a performance-based bonus.

Qualifications

• Knowledge of domestic and international quality/regulatory standards related to medical devices.
• Experience with quality management techniques (Lean, Six Sigma) and statistics.
• Understanding of product, technology and manufacturing processes and patient needs.

Responsibilities

• Participates in generation of quality documents throughout the product lifecycle.
• Advises and directs teams regarding compliance to procedures and regulations; implements changes.
• Ensures product quality meets requirements and documentation is complete prior to approval.
• Participates on core teams supporting new product development or design changes.
• Reviews and approves quality documents across the product lifecycle.
• Supports audits and corrective actions to maintain compliance of the QMS.
• Leads or participates in quality system improvement projects as needed.

Skills

Quality standards

Lean Six Sigma

Product knowledge

Education

Bachelor’s degree in engineering or science

Job description

Werfen is seeking a Senior Software Quality Engineer in Bedford, MA, to ensure lifecycle compliance, develop and apply methods, and support design, development, cybersecurity, verification and validation.

The role requires advanced analytical skills, risk management, and collaboration with project teams to achieve quality goals. We offer medical/dental/vision, 401k with employer match, paid time off, and a performance-based bonus.