Principal Software Quality Engineer

Job Information Number

ICIMS-2025-9026

Job function

QA&RA

Job type

Full-time

Location

Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States

Country

United States

About the Position Introduction

Werfen

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.

Overview

Job Summary

The position is responsible to ensure that the Design Control and Risk Management activities throughout the product lifecycle are in compliance with procedures, standards and regulations applicable to our SaMD, SiMD and Digital products. This position provides project-level leadership, develops, applies and implements methods, tools and practices to achieve product quality and compliance goals and requirements in the areas of design, development, cybersecurity, verification and validation, maintenance and service.

Responsibilities

Key Accountabilities

• Provide software expertise, leadership, and direction throughout the software development lifecycle with a focus on appropriate and thorough testing.
• Function as a quality expert for all product development activities by ensuring compliance to applicable standards and regulations.
• Maintain up-to-date knowledge on cybersecurity requirements and provide leadership and guidance regarding implementation and compliance.
• Write, review and approve software release documentation and change orders.
• Provide leadership and guidance in software change control for defect tracking and resolution.
• Function as the quality expert in software risk management processes throughout the entire software lifecycle.
• Provide expertise in non-product software validation for software tools used in product manufacturing, product testing and the quality system.
• Provide software quality engineering expertise to relevant CAPAs and audits.
• Maintain up-to-date knowledge on software development tools and processes.
• Participates in the generation and review of Design History File and Risk Management documents throughout the product lifecycle
• Advises and directs teams regarding compliance of software to procedures, standards and regulations including those related to cybersecurity and privacy requirements. Implements changes to procedures in alignment with evolving regulations.
• Participates on core teams supporting new product development or design changes
• Defends relevant quality topics in audits and supports corrective actions to improve and maintain compliance of the QMS
• Interprets regulations and procedures to ensure documents are sound and defensible to auditors and regulatory bodies.
• Provides input on product requirements, acceptance criteria, traceability, product evaluation, failure investigation and complaint analysis.
• Works with Project Management, Development, Testing, Marketing, Regulatory, Service, Distribution, Sales & Marketing, and others outside the company (as needed) to recommend or prepare corrective / preventive actions (CAPA)
• May supervise the work of others
• Leads cross-functional projects on technical and quality issues
• Identifies compliance gaps and suggest appropriate corrective actions as needed
• Supports internal and external audits
• Leads quality system improvement projects as required

Networking / Key Relationships

Qualifications

Minimum Knowledge & Experience required for the position :

Software Engineering Platforms and Applications (Cloud-Based Preferred)

Skills & Capabilities :

The ideal candidate for this position will exhibit the following skills and capabilities :

Travel requirements :

Approximately 15% of time

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

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 NAtalentacquisition@werfen.com 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

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