Overview

Be a part of the Quality team at our Healthcare Optics Research Laboratory and drive Quality for the development of unique software based biomedical devices in collaboration with world leading medical institutions. We are seeking an experienced Senior Quality Engineer (Sr Engineer, Quality Assurance) who can lead software design assurance and risk management activities and provide quality support of software development lifecycle processes and drive compliance.

Responsibilities

• As quality representative on the project’s core team or extended team, take responsibility of ensuring that all design control activities including design inputs, design and development planning, design reviews, design verification and validation, test method validation, and design transfer efforts are compliant and meet FDA’s expectations
• Review and approve design control and product documentation
• Ensure product safety by driving risk management activities including authoring risk management plans, interfacing with Medical Affairs, and facilitating and mentoring engineers on system risk assessments and FMEAs
• Ensure that software deliverables including software requirement specifications, software development plans, software architecture documents, and software verification and validation plans are compliant to software development lifecycle process procedures
• Act as a member of Issue Review Team meetings to ensure that software bugs are evaluated and addressed appropriately
• Provide guidance on the selection of statistical analyses and sample size for design verification and validation and other qualification and acceptance testing
• Support the successful transfer of products to manufacturing by ensuring the adequacy of process validation, design transfer plans, quality plans and supplier documentation
• May plan and execute internal audits against applicable quality system standards, regulations and internal procedures
• This position will require the incumbent to travel about 20 percent of the time

Qualifications

• Education: BS or higher degree in engineering, or similar
• Experience: 5 years minimum experience with a minimum of 3 years of Medical Device experience and a minimum of 3 years of Quality experience or design control experience, including experience in leading design control and risk management activities
• In-depth understanding of medical device design control and risk management
• Working knowledge of the requirements of FDA QSRs, ISO 13485, IEC 62304, IEC 60601 and ISO 14971
• Experience with JIRA/JAMA software tools and their implementation is a plus
• Certification as an internal lead auditor for QSRs and/or ISO 13485 is a plus
• Skills: Proficient in Microsoft Office. Experience in Minitab, JMP or similar statistical package