Werfen North America · 1 day ago
Principal Software Quality Engineer
Bedford, MA
Full-time
Hybrid
Lead/Staff
$160K/yr - $190K/yr
9+ years expWerfen North America is focused on ensuring compliance and quality in their software products throughout the lifecycle. The Principal Software Quality Engineer will lead design control and risk management activities, ensuring adherence to applicable standards and regulations, while providing expertise in software quality engineering and cybersecurity.
Health CareManufacturing
Responsibilities
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
Qualification
Required
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
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.)
Language: English
Deep knowledge of domestic and international quality/regulatory standards related to both Software in and Software as a Medical Device products (21 CFR Part 820, 21 CFR Part 11, ISO 13485, IEC 62304)
Demonstrates nuanced 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
Broad and thorough knowledge of engineering and science theory and principles, including R&D, quality control, manufacturing and design engineering
Understanding of the application of technical principles and engineering problem solving to resolve complex issues
Advanced understanding of software Development Life Cycle Models
Advanced understanding of Software Configuration Management (SCM)
Strong understanding of risk management and risk management tools (ISO 14971 & TIR 24971)
Advanced understanding of software development and testing processes
Preferred
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)
Membership on external standards organizations of industry groups with influence of our products – desirable
Benefits
Medical, dental, and vision insurance
401k plan retirement benefits with an employer match
Paid vacation
Sick leave
Participation in a commission plan
Performance-based bonus
Company
Werfen North America
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
Founded in 1959Bedford, Massachusetts, USA
1001-5000 employees
H1B Sponsorship
Werfen North America has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (12)
2023 (10)
2022 (2)
2021 (11)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Giovanni Russi
Chief Operating Officer
Dominique J.
Human Resources Business Partner
Recent News
2025-07-19
2025-05-17
2025-04-04
Company data provided by crunchbase