Werfen · 10 hours ago
Senior Quality Engineer, Risk Management
US-MA-Bedford
Full-time
Onsite
Senior Level, Lead/Staff
$125K/yr - $150K/yr
8+ years expWerfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. The position is responsible for ensuring that Design Control and Risk Management activities throughout the product lifecycle are in compliance with procedures, standards and regulations applicable to our products.
Health CareHospitalManufacturingMedical Device
Responsibilities
Serve as the risk management expert for all product development activities, ensuring compliance with applicable design control, risk management, usability, and regulatory requirements for IVD, Medical Device, SaMD and SiMD products
Own the development, maintenance, and continuous improvement of product Risk Management deliverables, ensuring alignment with ISO 14971, integration of post-market feedback, and a proactive focus on patient safety throughout the product lifecycle
Influence project direction and technical decision-making by embedding quality, compliance, risk controls, and patient safety requirements into product architecture, system requirements, verification and validation (V&V) strategies, and lifecycle management activities
Lead complex investigations and root cause analyses using structured methodologies to ensure that escalations, investigations and corrective/preventative actions (CAPA) are taken to remediate negative trends, prioritizing patient safety and quality
Provide input to failure investigations, complaint analysis, health hazard evaluations, and correction and removal activities
Support internal and external audits. Contribute to regulatory responses and documentation required by FDA, notified bodies, and other competent authorities
Build relationships with R&D, Manufacturing, Regulatory, Service, and Marketing partners, providing clear communication to senior leadership on quality risks, mitigations strategies, and program status
Provide guidance to quality engineers and cross-functional partners on risk management principles, design assurance practices, quality engineering tools and problem-solving methodologies
Perform other duties as assigned to support departmental and organizational objectives
Identify compliance gaps and drive appropriate corrective actions as needed
Lead quality system improvement projects as required
Qualification
Required
Bachelor's degree or equivalent in engineering or science
A minimum of 8 years of experience in medical devices, pharmaceuticals, diagnostic industry, or clinical laboratory or 5 years of experience with an advanced degree
Deep knowledge of domestic and international quality/regulatory standards related Medical Devices and both Software in and Software as a Medical Device
In depth knowledge of quality management techniques (Lean, Six Sigma) and statistical techniques required to measure and confirm significant changes
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
Demonstrates nuanced 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
Strong understanding of risk management and risk management tools (ISO 14971 & TIR 24971)
Duties necessitate 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
Preferred
ASQ Quality Engineering Certification - Desirable
LEAN/Six Sigma Certification - 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
Werfen is a developer, manufacturer and distributer of IVD testing solutions.
5001-10000 employees
H1B Sponsorship
Werfen 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
Dominique Petitgenet
Chief Operating Officer, Transfusion & Transplant
Ken Vogel, HCS
Human Resources Business Partner
Recent News
MarketScreener
2025-12-17
2025-12-08
Company data provided by crunchbase