- Maintain software development life cycle and maintenance processes.
- Partner with the SW Development Team and support the verification and validation processes to ensure accurate and reliable performance of the medical device software according to documented requirements.
- Manage the disposition of defects, enhancements, and customer feedback utilizing software tracking tools.
- Participate and/or lead Software risk management activities throughout the product development life cycle.
- Participate with the SW Development Team in software requirements and user story definition, and in reviews to ensure an appropriate level of rigor and testability.
- Participate in internal and external software-related portions of audits as a subject matter expert; monitor and audit the software quality processes for compliance, effectiveness, continued alignment with applicable regulatory and statutory requirements, and opportunities for improvement.
- Maintain the non-product software validation process by developing and executing validation plans, functional and user requirement specifications, IQ/OQ/PQ protocols, and validation reports.
- Assist and guide internal system owners in the validation of non-product software validations.
- Other duties as assigned.
- Minimum of a BS in Engineering, Computer Science, or related discipline.
- 6+ years of related experience, including 4+ years working in a highly regulated environment; software related role supporting quality, new product development, or manufacturing.
- Knowledge of medical device product development lifecycle, including design controls, risk management, software configuration, design verification, and validation preferred.
- Strong working knowledge of IEC 62304, ISO 13485, FDA 21CFR PART820, FDA 21CFR Part 11, ISO 14971, and related medical device regulations.
-
Quality Assurance Automation Engineer
6 days ago
Dassault Systemes Waltham, United StatesEnvie de rejoindre et de grandir au sein d'une equipe ayant la passion du changement et de l'innovation ? Motive(e) a l'idee de collaborer a des projets au plus pres des enjeux de nos clients ? · Pour accompagner la forte croissance de notre groupe, nous recrutons un(e) Supply Ch ...
-
Quality Engineer
1 week ago
Spectrum Industries Cambridge, United StatesDigital transformation. Sustainability. Peacekeeping. Exciting tasks that we at Diehl, in our five subgroups Metall, Controls, Defence, Aviation, and Metering, and our over employees are working on with high pressure. Discover fascinating technologies and apply now. In a family-o ...
-
Supplier Quality Engineer
6 days ago
Boston Dynamics Waltham, United StatesAs a Supplier Quality Engineer at Boston Dynamics, you will manage our component supply base to ensure that our suppliers are delivering high-quality products to our assembly operations for both our Spot and Stretch robots. Every day, you will collaborate with our Manufacturing t ...
-
Quality Engineer
5 days ago
Viva USA, Inc. Auburndale, United States PermanentTitle: Quality Engineer - Onsite · Description: · Responsibilities: · Disposition non-conforming material (NCMR). · Lead and/or participate in product complaint investigations leading to root cause. · Propose, lead, initiate and follow-up on Corrective Action and Preventive Ac ...
-
Senior Quality Engineer
1 week ago
Exergen Corporation Watertown, United StatesExergen Corporation is the recognized world leader in medical non-invasive temperature technology. Exergen invented and manufactures non-invasive temperature measurement devices providing lower cost, higher accuracy, less invasiveness, and greater reliability than ever previously ...
-
Director of Quality Engineering
3 days ago
Vicarious Surgical Waltham, United StatesVicarious Surgical is hiring a Director of Quality to lead and grow our quality department based in Waltham, MA. Accountable to ensure all products are designed and produced to meet their specifications and comply with industry regulatory requirements. Create and implement best p ...
-
Director of Quality Engineering
2 weeks ago
Vicarious Surgical Waltham, United StatesJob Description · Job DescriptionVicarious Surgical is hiring a Director of Quality to lead and grow our quality department based in Waltham, MA. Accountable to ensure all products are designed and produced to meet their specifications and comply with industry regulatory requirem ...
-
Quality Engineer I
3 days ago
Nova Biomedical Waltham, United StatesCareer Opportunities with Nova Biomedical Corporation · Nova Biomedical is an Equal Opportunity Employer in compliance with Affirmative Action in hiring and promoting women, minorities, veterans and individuals with disabilities. · Nova Biomedical is hiring a · Quality Engineer ...
-
Quality/Supplier Engineer
1 week ago
Convergent Dental Waltham, United StatesJob Description · Job Description · Benefits: · 401(k) · 401(k) matching · Competitive salary · Dental insurance · Flexible schedule · Health insurance · Paid time off · Parental leave · Training & development · Vision insurance · Convergent Dental has developed and launched S ...
-
Quality/Supplier Engineer
4 weeks ago
Convergent Dental Inc Waltham, United StatesJob Description · Job Description · Convergent Dental has developed and launched Solea, a dental laser that can cut tissue in the oral cavity without anesthesia. Solea has quickly become the #1 hard and soft tissue laser in dentistry. This is an exciting time to join our amazing ...
-
Quality Automation Engineer III
2 weeks ago
ZoomInfo Waltham, United StatesQA Engineer III Waltham Massachusetts Hybrid · As a Quality Assurance Engineer, you will work within a scrum team. You will be responsible for designing and implementing test solutions to measure and validate the infrastructure and functionality of ZoomInfo directories. You will ...
-
Quality/Supplier Engineer
2 weeks ago
Convergent Dental Inc Waltham, United StatesJob Description · Job DescriptionBenefits:401(k) · 401(k) matching · Competitive salary · Dental insurance · Flexible schedule · Health insurance · Paid time off · Parental leave · Training & development · Vision insurance · Convergent Dental has developed and launched Solea, a d ...
-
Quality Automation Engineer III
2 weeks ago
ZoomInfo Waltham, United StatesQA Engineer III Waltham Massachusetts Hybrid · As a Quality Assurance Engineer, you will work within a scrum team. You will be responsible for designing and implementing test solutions to measure and validate the infrastructure and functionality of ZoomInfo directories. You will ...
-
Senior Software Quality Engineer
1 week ago
Vicarious Waltham, United StatesAs a Senior Software Quality Engineer, you will be a subject matter expert of compliance related to the development lifecycle and maintenance processes of product software and software development tools and validation and maintenance of non-product software. You will be responsib ...
-
Quality Engineer I
3 days ago
Nova Biomedical Watertown, United StatesNova Biomedical is hiring a Quality Engineer I on-site (hybrid) in our Waltham, MA facility. This role will support Quality Assurance activities within the corporate Quality Management System (QMS). Responsibilities include providing expertise and general oversight for the manage ...
-
Design Quality Engineer
3 days ago
WiTricity Watertown, United StatesWiTricity is seeking an experienced Design Quality Engineer at our Watertown, MA headquarters to join our Global Engineering and Quality team. This role will work closely with our global product development and manufacturing teams to ensure and improve the quality and reliability ...
-
Design Quality Engineer
1 week ago
WiTricity Watertown, United StatesJob Description · Job DescriptionWiTricity is seeking an experienced Design Quality Engineer at our Watertown, MA headquarters to join our Global Engineering and Quality team. This role will work closely with our global product development and manufacturing teams to ensure and im ...
-
Design Quality Engineer
2 weeks ago
WiTricity Watertown, United StatesJob Description · Job DescriptionWiTricity is seeking an experienced Design Quality Engineer at our Watertown, MA headquarters to join our Global Engineering and Quality team. This role will work closely with our global product development and manufacturing teams to ensure and im ...
-
Head of Quality Engineering
19 hours ago
Constant Contact Watertown, United States Full timeAt Constant Contact, we are seriously awesome people who take ownership and make an impact by operating with the mindset, integrity and courage of a small business owner. There's something so profoundly rewarding about knowing that your work is empowering people everywhere to pur ...
-
Quality Automation Engineer III
2 weeks ago
ZoomInfo Technologies LLC Waltham, United StatesJob Description · Job DescriptionAt ZoomInfo, we encourage creativity, value innovation, demand teamwork, expect accountability and cherish results. We value your take charge, take initiative, get stuff done attitude and will help you unlock your growth potential. One great choic ...
Senior Software Quality Engineer - Waltham, United States - Vicarious Surgical
Description
As a Senior Software Quality Engineer, you will be a subject matter expert of compliance related to the development lifecycle and maintenance processes of product software and software development tools and validation and maintenance of non-product software. You will be responsible for quality system support for software R&D projects; generation and/or review of software quality documentation; providing inputs to software R&D designs; assisting with the development of verification and validation strategies and improving quality processes for product software systems.
Vicarious Surgical is a next generation robotics company developing a disruptive technology with the goal of increasing the efficiency of surgical procedure, improving patient outcomes, and reducing healthcare costs.
Key Responsibilities
About You
Together, we share a love for learning and we are passionate teachers. As a company, we set ambitious goals and individually, we share in that ambition. At the office, we enjoy each other's company during monthly social, catered lunches and company celebrations.
Please note that at Vicarious Surgical, we follow COVID-19 safety protocol, which may include compliance with vaccination, testing and masking requirements.
