Principal Software Quality Engineer

Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States

Country

United States

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.

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.

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

• Manufacturing/Operations
• Manufacturing Engineering
• Regulatory Affairs
• Research & Development
• Service

Minimum Knowledge & Experience required for the position:

• Bachelor's of Science degree plus a minimum of 12 years related experience or Master's Degree plus a minimum of 9 years related experience or waiver based on experience.
• ASQ SQE certification preferred
• Additional experience working in or knowledge of:
  • Software Engineering Platforms and Applications (Cloud-Based Preferred)
  • Project design, validation, quality plans and risk management (including human factors and Cybersecurity)
  • Preparing submissions, complaint systems and/or authorities reporting activities
  • AI/ML models (desirable)
• Solid knowledge and experience working with medical device international regulations (FDA QSR, EU Medical Device Regulation, etc.) and related standards (ISO 13485, ISO 14971, IEC 62304, IEC 62366, TIR 57, etc.)

Skills & Capabilities:

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

• Deep knowledge of domestic and international…