Location: Cambridge, MA
US citizens and Greencard holders 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 Medical Device Senior Software Quality Engineer (Sr Engineer, Software 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: 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.
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 HYBRID: This position offers a hybrid work schedule requiring you to be in the office 2 days a week and an option to work from home 3 day out of the week (unless a specific business need arises requiring in office attendance on other days). Note that work schedules and office reporting requirements may change from time to time based on business needs.
Quality Assurance (QA) jobs entail roles focused on ensuring that products or services meet established standards and customer expectations. People in QA positions are responsible for designing testing processes, creating test plans, identifying defects, and preventing defects by examining the production process. They aim to enhance product reliability and actively work to maintain quality consistency. QA roles often require keen attention to detail, strong problem-solving skills, and an understanding of both product specifications and customer needs. QA is an integral part of product development and maintenance, bridging the gap between the manufacturing processes and the end users to ensure a satisfactory experience.
Quality Assurance (QA) jobs involve the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. The primary goal is to identify defects and issues before the product reaches the customer, thereby ensuring customer satisfaction and maintaining the reputation of an organization. QA roles often require attention to detail, strong problem-solving skills, and a good understanding of industry-specific regulations and standards. These jobs can vary widely, from software testing to food safety inspection, but they universally function as a critical checkpoint in the production and delivery process of goods or services.
Quality Assurance (QA) jobs involve the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. The primary goal is to identify defects and issues before the product reaches the customer, thereby ensuring customer satisfaction and maintaining the reputation of an organization. QA roles often require attention to detail, strong problem-solving skills, and a good understanding of industry-specific regulations and standards. These jobs can vary widely, from software testing to food safety inspection, but they universally function as a critical checkpoint in the production and delivery process of goods or services.
Quality Assurance (QA) Jobs encompass roles focused on ensuring that products or services meet established standards of quality, reliability, and performance. These positions typically involve identifying defects, designing test procedures, conducting tests, and making improvements. Key characteristics of QA jobs include attention to detail, a strong understanding of quality metrics, the ability to analyze data, and problem-solving skills. Individuals in QA roles work closely with development teams and are critical in maintaining customer satisfaction by preventing errors and enhancing the user experience.
