Senior Software Quality Engineer

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

Introduction

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 the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

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. Implement 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 judgement 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

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, 401(k) 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.

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.