Director of Quality Engineering

2 weeks ago

Waltham, United States Vicarious Surgical Full time
Job DescriptionJob Description

Vicarious 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 practice quality vision, strategy, and processes to improve business performance.

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.

This is a terrific opportunity for a leader of Quality in the medical device industry to join our company at a very exciting time and be a key member of a team of mission-driven and kind individuals with diverse experiences to lead Vicarious into market disruption.

Responsibilities:

  • Lead a team of direct and indirect quality functions with accountability for the company's quality assurance and compliance goals and ensuring compliance with the FDA's Quality System Regulation (QSR), ISO 13485, EU MDR.
  • Lead and responsible for all Quality Management System (QMS) efforts to ensure product compliance with FDA QSR, ISO 13485, and IEC 62304 such as Design Controls, Risk Management, Software Development Lifecycle and Maintenance Processes (SDLC), Production and Process Controls, Complaints, CAPA investigations and data analysis for a complex robotic medical device.
  • Lead the development of a Product Quality Plan & Test Strategy for inspecting, testing, and evaluating product compliance and assures products are high quality before product launch through skilled application of advanced product quality planning and effective utilization of quality tools (FMEA, DOE, DFM).
  • Drive the use of proven statistical methods and tools to provide product reliability data on product performance, working closely with the R&D engineering team.
  • Lead the development of a strong Supplier Quality Management Strategy.
  • Develop and manage budgets, schedules, and performance requirements.
  • Lead Risk Management File and assist with Usability Engineering related activities (FMEAs, Hazard Analysis, Risk Plans, Reports) for product development and commercially released product per ISO 14971 and IEC 62366-1.
  • Lead design quality activities, for product development starting from requirements phase through development, V&V, design transfer to commercialization phase activities.
  • Review software engineering specifications, protocols, and reports to assure that adequate quality requirements are met.
  • Non-product software validation management for software quality tools (eQMS, ALM, ERP, etc.).
  • Responsible for implementation of post market surveillance reviews and assisting with clinical evaluation reports.
  • Participate in regulatory activities, including FDA De Novo, 510(K), and tech file creation and submissions and Notified Body assessments.
  • Create and/or update the company's Quality Management System procedures, instructions, forms, and records to meet regulatory requirements.
  • Create and/or approve Document Change Orders.
  • Lead the continued talent development of the quality team and recruit additional quality talent commensurate with the growth of the company.
  • Other duties as assigned.

About You

  • Bachelor's Degree in Engineering or another technical discipline, or equivalent experience/ quality certifications.
  • 15+ years of related experience, including working with a complex electro-mechanical medical devices in a Quality Engineering, Quality Systems, or Quality Assurance FDA and/or ISO regulated industry.
  • Strong communication skills (both verbal and writing), capable of presenting Quality updates and strategy to executive management.
  • Strong understanding of ISO 13485, FDA 21 CFR Part 820, EU Medical Device Regulations .
  • Experience or strong desire and capabilities to work in a start-up medical device company that includes a fast-paced development environment.
  • Proficient in auditing quality systems.
  • Able to create and execute training for team members on quality processes and systems.
  • Able to clearly identify, define, and communicate technical, process, and quality related issues or improvements with internal and external personnel.
  • Strong skills in word processing, spreadsheet, presentation, manufacturing and database software.
  • Demonstrated skills in managing priorities and coordinating team activities while supporting and executing cross-functional team decisions; mentoring capabilities and people management skills are helpful.

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.

  • Director of Quality Engineering

    2 days ago

    Waltham, United States Vicarious Surgical Full time

    Vicarious 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 practice quality vision, strategy, and processes to improve business performance....

  • Director of Quality Engineering

    2 days ago

    Waltham, MA, United States Vicarious Surgical Inc. Full time

    Vicarious 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 practice quality vision, strategy, and processes to improve business...

  • Director of Quality Engineering

    2 days ago

    Waltham, MA, United States Vicarious Surgical Full time

    Vicarious 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 practice quality vision, strategy, and processes to improve business performance....

  • Director, Quality Engineering

    2 days ago

    Waltham, MA, United States Vicarious Surgical Inc. Full time

    Vicarious 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 practice quality vision, strategy, and processes to improve business performance....

  • Director Of Quality Assurance

    5 days ago

    Waltham, United States RPM ReSearch Full time

    Title: Director of Quality Assurance CDMO Location: Greater Boston, MA area Generous Relocation Assistance provided Onsite Presence Required JOB SUMMARY The Director of Quality Assurance is responsible for managing all aspects of the Quality Assurance while developing, implementing, and maintaining an effective Quality Management System under appropriate...

  • Director, Quality Systems and Compliance

    2 weeks ago

    Waltham, United States ElevateBio Full time

    ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential. The Role: The...

  • Senior Mechanical Engineer

    1 month ago

    Waltham, Massachusetts, United States Boston Engineering Full time

    Company DescriptionBoston Engineering improves the way people work and live through innovative product design and novel engineering. Our teams of product designers and engineers for the Medical, Commercial, and Defense sectors. Experts in robotics, control systems, embedded systems, DFX, and digital transformation, we are ISO 9001 and ISO 13485 certified....

  • Director, Clinical Development Quality Assurance and Compliance

    5 days ago

    Waltham, United States Invivyd Inc. Full time

    ABOUT US Invivyd is on a mission to rapidly and perpetually deliver antibody-based therapies that protect vulnerable people from the devastating consequences of circulating viral threats, beginning with SARS-CoV-2. The company's proprietary INVYMAB platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody...

  • Quality Automation Engineer III

    1 month ago

    Waltham, United States ZoomInfo Full time

    QA Engineer III Waltham Massachusetts HybridAs 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 report to a Manager of Quality Engineering. What you will do:  Actively...

  • Quality Automation Engineer III

    2 weeks ago

    Waltham, United States ZoomInfo Full time

    QA Engineer III Waltham Massachusetts HybridAs 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 report to a Manager of Quality Engineering. What you will do:  Actively...

  • Quality Automation Engineer III

    5 days ago

    Waltham, United States ZoomInfo Technologies LLC Full time

    At 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 choice can change everything. Thrive with us at ZoomInfo. QA Engineer III Waltham Massachusetts Hybrid As a Quality...

  • Senior Mechanical Engineer

    2 days ago

    Waltham, United States Boston Engineering Corporation Full time

    Boston Engineering improves the way people work and live through innovative product design and novel engineering. Our teamsofproduct designers and engineers for the Medical, Commercial, and Defense sectors. Experts in robotics, control systems, embedded systems, DFX, and digital transformation, we are ISO 9001 and ISO 13485 certified. Seeking innovative,...

  • Senior Mechanical Engineer

    3 weeks ago

    Waltham, United States Boston Engineering Corporation Full time

    Boston Engineering improves the way people work and live through innovative product design and novel engineering. Our teams of product designers and engineers for the Medical, Commercial, and Defense sectors. Experts in robotics, control systems, embedded systems, DFX, and digital transformation, we are ISO 9001 and ISO 13485 certified. Seeking innovative,...

  • Quality Professional II, Quality Audits

    4 days ago

    Waltham, United States ElevateBio Full time

    ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential. The Role: The...

  • Senior Mechanical Engineer

    1 month ago

    Waltham, United States Boston Engineering Corporation Full time

    Job DescriptionJob DescriptionCompany DescriptionBoston Engineering improves the way people work and live through innovative product design and novel engineering. Our teams of product designers and engineers for the Medical, Commercial, and Defense sectors. Experts in robotics, control systems, embedded systems, DFX, and digital transformation, we are...

  • Senior Director, GMP Quality Assurance, Commercial

    1 month ago

    Waltham, United States Taylor Strategy Partners Full time

    Description Sr. Director, GMP Quality Assurance, Commercial Position Summary: The Senior Director Quality Assurance will provide expertise and guidance on Good Manufacturing Practice for all commercial products. They will adhere to applicable regulations and work with stakeholders to proactively identify compliance issues and risks and implement corrective...

  • Senior Director, GMP Quality Assurance, Commercial

    1 week ago

    Waltham, United States Taylor Strategy Partners Full time

    Description Sr. Director, GMP Quality Assurance, Commercial Position Summary: The Senior Director Quality Assurance will provide expertise and guidance on Good Manufacturing Practice for all commercial products. They will adhere to applicable regulations and work with stakeholders to proactively identify compliance issues and risks and implement corrective...

  • Quality Professional II, Quality Audits

    5 days ago

    Waltham, United States ElevateBio Full time

    ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential. The Role: The...

  • Director/Senior Director, Quality Management

    2 days ago

    Waltham, MA, United States Blackwomenintech Full time

    For the expansion of our BIS team, argenx is looking for a Senior Director BIS G&A/CMC. The Senior Director BIS G&A/CMC is the single point of accountability for strategy and implementation for all information, processes and systems to address the business needs and challenges of the CMC, Manufacturing, Supply Chain, Legal, Finance and Human Resources...

  • Quality Assurance Automation Engineer

    4 days ago

    Waltham, United States Dassault Systèmes Full time

    Here at DASSAULT SYSTEMES (3DS), we empower people with passion to change the world. Let us open new horizons together with the power of 3DEXPERIENCE virtual universe! We are seeking a Quality Assurance Automation Engineer, you will be working on automated testing which will include designing, implementing, and maintaining tests. It will additionally involve...