- 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
- 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.
- 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.
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Director of Quality Engineering - Waltham, United States - Vicarious Surgical
Description
Job 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 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:
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.
