Senior Software Quality Engineer

Werfen North America; Bedford (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Senior Software Quality Engineer to ensure product quality and compliance throughout the lifecycle. In this role, you will develop and implement quality methods and tools, while collaborating with project teams to meet product quality goals. With a focus on design, development, and verification, you will play a crucial role in driving process improvements and maintaining compliance with regulations. If you are passionate about quality assurance in the medical equipment industry and have substantial experience, this is an exciting opportunity to make a significant impact.

Qualifications

• Minimum of 8 years of experience in medical devices or 5 years in a clinical laboratory.
• Management may substitute relevant work experience for a degree.

Responsibilities

• Ensures product quality meets requirements and documentation is complete.
• Participates in generating quality documents throughout the product lifecycle.
• Advises teams on compliance to procedures and standards.

Skills

Knowledge of quality management techniques (Lean, Six Sigma)

Knowledge of domestic and international quality/regulatory standards

Statistical techniques

Judgment in applying regulatory requirements

Education

Bachelor's degree in engineering or science

Job description

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Position Summary

The Senior Software Quality Engineer position is responsible for ensuring that activities throughout the product lifecycle comply with procedures, standards, and regulations applicable to our products. The Sr SWQE independently develops, applies, and implements methods, tools, and practices while working with project teams to achieve product quality goals in areas such as design, development, cybersecurity, verification and validation, maintenance, and service. This role requires advanced skills in analyzing information, reviewing technical reports, promoting process improvement, requirements development, risk management, product development, verification and validation, and cybersecurity.

Responsibilities

• Participates in generating quality documents throughout the product lifecycle.
• Advises and directs teams regarding compliance to procedures, standards, and regulations. Implements changes to procedures in line with evolving regulations.
• Ensures product quality meets requirements and documentation is complete prior to approval.
• Participates in core teams supporting new product development or design changes.
• Reviews and approves quality documents throughout the product lifecycle.
• Supports audits and corrective actions to maintain compliance of the QMS.
• Identifies compliance gaps and takes corrective actions as needed.
• Participates in and may lead quality system improvement projects.
• Performs other duties as assigned, with reasonable accommodations for individuals with disabilities.

Internal Networking/Key Relationships

Works closely with other functions to generate compliant documents, interpret quality procedures, standards, and regulations. Communicates quality requirements effectively and influences others to improve quality and compliance.

Skills & Capabilities

• Knowledge of domestic and international quality/regulatory standards related to our products.
• Knowledge of quality management techniques (Lean, Six Sigma) and statistical techniques.
• Understanding of products, technology, manufacturing processes, and their impact on customers and patients.
• Judgment in applying regulatory requirements to data review, reports, design changes, risk management, etc., ensuring compliance and business objectives.

Qualifications

Minimum of a Bachelor's degree in engineering or science. At least 8 years of experience in medical devices, pharmaceuticals, diagnostic industry, or 5 years in a clinical laboratory. Management may substitute relevant work experience for a degree or make exceptions.

Additional Details

• International Mobility Required: No
• Travel Requirements: Approximately 10%
• Seniority level: Mid-Senior level
• Employment type: Full-time
• Industry: Medical Equipment Manufacturing