Senior Software Quality Engineer

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

Werfen is a growing, family‑owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals with the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Overview

Position Summary

The Senior Software Quality Engineer position is responsible to ensure that activities throughout the product lifecycle are in compliance with procedures, standards and regulations applicable to our products. In this capacity the Sr SWQE independently develops, applies and implements methods, tools and practices while working with project teams to achieve product quality goals and requirements in the areas of design, development, cybersecurity, verification and validation, maintenance and service. This is a technically focused role requiring advanced skills in analyzing information, reviewing technical reports, promoting process improvement, requirements development, risk management, product development, verification and validation, and cybersecurity.

Key Accountabilities

• Participates in the generation of quality documents throughout the product lifecycle.
• Advises and directs teams regarding compliance to procedures, standards and regulations. Implements changes to procedures in alignment with evolving regulations.
• 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 throughout the product lifecycle.
• Supports audits and corrective actions to improve and maintain compliance of the QMS.
• Identifies compliance gaps and takes appropriate corrective actions as needed.
• Participates in and may lead quality system improvement projects as required.
• Performs other duties and responsibilities as assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Budget Managed (if Applicable)

• N/A

Internal Networking/Key Relationships

To be determined based on department needs, to include interactions such as:

• Works closely with other functions to generate compliant documents by interpreting and explaining quality procedures, applicable standards, regulations and best practices.
• Able to effectively communicate quality requirements to a broad population of constituents.
• Ability to negotiate and influence others in establishing direction toward improved quality and enhanced compliance.

Skills & Capabilities

• Working knowledge of domestic and international quality/regulatory standards related to our products.
• Knowledge of quality management techniques (Lean, Six Sigma) and statistical techniques required to measure and confirm significant changes.
• Working knowledge of products, technology and manufacturing processes including impact on customers and patient requirements.
• Demonstrates judgment commensurate with experience regarding application of regulatory requirements to data review, reports, design changes, risk management, etc. to ensure compliance and achieving business objectives. Demonstrated understanding of risk‑based approach to processes and decisions.

Qualifications

Minimum Knowledge & Experience Required for the Position:

Education: Bachelor’s degree or equivalent in engineering or science.

Experience: A minimum of 8 years of experience in medical devices, pharmaceuticals, diagnostic industry, or clinical laboratory of 5 years of experience.

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

International Mobility Required

• No

Travel Requirements

• Approximately 10%

The annual base salary range for this role is currently $130K - $160K. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance‑based bonus.

Closing

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Equal Opportunity Employer

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact [e-mail] for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com