Senior Software Quality Engineer

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.

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 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.

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…