Senior Vice President of Quality Assurance

2 weeks ago


Massachusetts, United States Connect Life Science Full time

Position Overview:

Connect Life Science, a pioneering entity in the medical device sector, is on the lookout for a seasoned Vice President of Quality to spearhead their quality management initiatives as they transition innovative products into the market. This pivotal leadership position entails comprehensive oversight of quality assurance and regulatory adherence, ensuring excellence throughout the stages of product development, manufacturing, and market introduction.

Ideal Candidate Profile:

The successful candidate will possess a robust background in the medical device arena, showcasing a deep understanding of quality frameworks, regulatory mandates, and the intricacies of product commercialization. Exceptional leadership qualities, strategic foresight, and the ability to thrive in a dynamic, highly regulated landscape are critical.

Core Responsibilities:

  • Direct quality systems and guarantee adherence to FDA, ISO, and other regulatory requirements.
  • Champion quality initiatives from the inception of product development to successful market entry.
  • Oversee internal and external audits, implement corrective measures, and drive continuous enhancement efforts.
  • Engage collaboratively with Research & Development, Manufacturing, and Regulatory Affairs teams.
  • Provide strategic guidance to facilitate effective product launches and ongoing market support.

Required Qualifications:

  • Significant experience in quality leadership roles within the medical device industry.
  • In-depth knowledge of regulatory compliance, risk assessment, and quality management systems (ISO 13485, FDA 21 CFR Part 820).
  • Demonstrated success in guiding products from the development phase to market readiness.
  • Strong capabilities in leadership, communication, and problem-solving.

This role presents a distinctive opportunity to contribute to a forward-thinking organization at a crucial juncture in its evolution.



  • Massachusetts, United States Connect Life Science Full time

    Company Overview:Connect Life Science is a pioneering organization in the medical device sector, dedicated to advancing healthcare through innovative solutions. We are currently in search of a seasoned Vice President of Quality to spearhead our quality management efforts as we bring new products to market.Role Overview:The Vice President of Quality will play...


  • Massachusetts, United States Life Science People Full time

    Vice President of Translational ResearchLife Science People is on the lookout for an accomplished and innovative Vice President of Translational Research to spearhead our translational initiatives. The ideal candidate will serve as a pivotal link between preclinical investigations and clinical advancements, ensuring that groundbreaking scientific findings...


  • Boston, Massachusetts, United States Flywire Full time

    About the RoleThe Vice President of Investor Relations will play a pivotal role in shaping Flywire's external communications strategy, fostering relationships with shareholders, analysts, and potential investors.Key ResponsibilitiesDevelop and execute comprehensive investor relations strategies and plans aligned with the company's business objectives and...


  • Massachusetts, United States PROJECTUS Full time

    QUALITY ASSURANCE ENGINEER (Medical Devices/ISO13485)PROJECTUSPermanent PositionROLE OVERVIEW:Are you ready to take on a new challenge in the Medical Devices sector?Have you reached a standstill in your current role?Are you looking for greater responsibilities but feel limited by your current organization's size?This is your opportunity.PROJECTUS is a...


  • Massachusetts, United States Catalyst Life Sciences Full time

    Position Overview: We are collaborating with Catalyst Life Sciences, a prominent player in the medical device sector, to identify a Quality Assurance Engineer for a contract role. This position is crucial as the organization navigates a significant merger, and the selected candidate will undertake comprehensive evaluations of existing products to ensure...


  • Boston, Massachusetts, United States Shawmut Full time

    Overview:At Shawmut Design and Construction, we take pride in our culture as a 100% employee-owned organization, recognized with over 83 awards for being a Best Place to Work. Our accolades include recognition from Fortune Magazine, as well as Great Place to Work's Best Workplace for Parents, and one of America's Best Employers by Forbes.Here's a glimpse...


  • Massachusetts, United States enVision Staffing Solutions Full time

    enVision Staffing Solutions is collaborating with a Global Manufacturing firm dedicated to providing essential product solutions for the Life Science and Process Industries.We are seeking a QUALITY AND COMPLIANCE MANAGER to spearhead the development, implementation, and maintenance of quality standards while fulfilling operational objectives.Compensation...


  • Massachusetts, United States Novo Nordisk Full time

    About the Department The Finance and Operations dept. brings insights and intelligence to inform decision making & drives digitalization and business solutions to attain NNI goals. Finance and Operations works closely across the organization to guide enterprise-wide resource allocations, investment choices, drive core operations and develop insights to drive...


  • Billerica, Massachusetts, United States Nuclera Full time

    Company Overview:Nuclera is a venture-backed biotechnology firm based in Cambridge, UK, with substantial operations in Boston, USA. We are at the forefront of making rapid protein expression and purification accessible at the benchtop level through our innovative eProtein Discovery™ System. Our mission is to enhance human health and empower life science...


  • Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time

    Position OverviewThe Head of GMP Quality Assurance is responsible for ensuring adherence to regulatory standards, including 21 CFR 210/211, 312, EudraLex Vol. 4, and ICH guidelines. This role involves overseeing quality assurance processes and prioritizing quality-related tasks for both clinical and commercial partners.Key ResponsibilitiesEnsure compliance...


  • Wilmington, Massachusetts, United States Sirtex Full time

    Job SummaryThe Quality Assurance Technician plays a vital role in ensuring that only products meeting defined quality and regulatory standards leave the manufacturing location. This position requires a detail-oriented individual capable of working independently in a clean room environment and with the demands of production timelines and commitments.Key...


  • Massachusetts, United States GForce Life Sciences Full time

    Position OverviewGForce Life Sciences is collaborating with a leading Fortune 500 Medical Device Company to recruit a Visual Inspection Consultant. This role is essential for addressing and mitigating AQL (Acceptable Quality Level) discrepancies.Role ResponsibilitiesThe Visual Inspection Subject Matter Expert (SME) will be instrumental in upholding the...


  • Marlborough, Massachusetts, United States Quest Diagnostics Full time

    Overview:The Quality Assurance Supervisor is responsible for overseeing the training, development, and management of departmental staff; coordinating and scheduling departmental activities; overseeing the public health reporting process; ensuring adherence to laboratory policies and procedures; and managing departmental operations in a cost-effective manner....


  • Milford, Massachusetts, United States Waters Corporation Full time

    Overview:This engaging position offers comprehensive support for both the Quality Control Laboratory and Production sectors, collaborating closely with the Senior QA Laboratory Engineer and Operational Quality Engineers at Waters Corporation. The Laboratory Engineer III will conduct thorough investigations and analyses of diverse samples to support Quality,...


  • Norwood, Massachusetts, United States MES Solutions, Inc. Full time

    Position Overview:Are you a Medical Assistant (MA) or Certified Nursing Assistant (CNA) seeking a transition from a clinical environment to a remote role? If so, MES Solutions, Inc. is in search of a Quality Assurance Specialist to join our dedicated team. Your primary responsibility will be to meticulously review medical documentation, ensuring precision by...


  • Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time

    Job Description**Key Responsibilities:**Ensure compliance with regulatory requirements, including 21 CFR 210/211, 312, EudraLex Vol. 4, and ICH.Provide oversight and management of quality-related tasks and priorities for clinical and commercial vendors/partners.Develop and execute continuous quality assurance improvements.Lead the GMP QA department,...


  • Massachusetts, United States Replimune Group Full time

    Overview The Vice President of CMC is responsible for the leadership and management of Replimune’s Manufacturing function at the Framingham site and the supporting global Process Development function. The role holder will oversee all aspects of drug substance and drug product development and scale up, technology transfer, clinical and commercial...


  • Massachusetts, United States Talent Groups Full time

    Job Summary:Talent Groups is seeking a highly skilled Medical Device Quality Assurance Specialist to join our team. As a key member of our organization, you will play a pivotal role in ensuring the quality and compliance of our medical devices.Key Responsibilities:Manage and Oversee Quality Management System (QMS) Records: Develop, maintain, and resolve QMS...


  • Massachusetts, United States Tecomet, Inc Full time

    Job Title: Worldwide Quality Assurance and Regulatory Affairs Systems LeaderTecomet, a leading global provider of innovative solutions for the medical device industry, is seeking an experienced leader to oversee its worldwide Quality Assurance and Regulatory Affairs Systems.Job Summary:As a key member of our leadership team, you will be responsible for...


  • Wilmington, Massachusetts, United States Sirtex Full time

    Job OverviewThe Quality Assurance Specialist plays a crucial role in maintaining the integrity of products at Sirtex. This position is essential for ensuring that all products meet established quality and regulatory benchmarks before they are dispatched from the manufacturing facility.This role demands a meticulous individual who can operate autonomously in...