Senior Quality Engineer, Risk Management

Werfen • Bedford, MA

8d

About The Position

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. This position provides project-level leadership, independently develops, applies and implements methods, tools and practices to achieve product quality and compliance goals in the areas of design, development, risk management, production, distribution, maintenance and service. Candidates for the position are expected to lead by example, in alignment with company values.

Requirements

• 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)
• Additional experience working in or knowledge of: Project design, validation, quality plans, and risk management (including human factors and Cybersecurity).
• Preparing regulatory submissions, complaint systems, and/or medical device reporting activities.
• Strong knowledge and experience working with FDA, Medical Device, and IVD regulations and related standards (ISO 13485, ISO 14971, IEC 62304, etc.)
• 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 or 5 years of experience with an advanced degree
• 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.

Nice To Haves

• ASQ Quality Engineering Certification - Desirable
• LEAN/Six Sigma Certification - Desirable

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.

Benefits

• This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave.
• Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level