Jobs
>
Étreux

    Quality Assurance Manager - Boston, United States - Veritas Search Group

    Veritas Search Group
    Veritas Search Group Boston, United States

    3 weeks ago

    Default job background
    Description

    Senior Manager, Quality Assurance (Med Device / Combination Products)

    Do you have the right skills and experience for this role Read on to find out, and make your application.

    Location: Fully Remote

    Scope of Work:

    The Senior Manager, Quality Assurance (Med Device / Combination Products) will be responsible for ensuring compliance with quality standards for pharmaceuticals, medical devices, and combination products. This role involves implementing integrated quality systems that meet federal and international regulations.

    Key Responsibilities:

    Ensure compliance with quality standards by implementing phase-appropriate integrated quality systems for pharmaceuticals, medical devices, and combination products.

    Implement continuous improvement throughout R&D and Commercial Operations, and conduct Management Reviews, focusing on Key Performance Indicators that support Quality Management Reviews.

    Lead or participate in quality investigations, including the generation and follow-up of metrics for the overarching QMS, including Issue/Deviation, Corrective and Preventive Action (CAPA), Supplier Corrective Action Requests (SCAR), and Change Control.

    Oversee the effectiveness of production processes, specifications, and test methods in conjunction with Quality Control/product disposition.

    Supervise quality compliance activities related to the development and implementation of policies, procedures, training, controls, measurements, corrective/preventive action, and audits (GCP, GMP, QSR, and ISO 13485:2016).

    Oversee quality compliance activities related to the review of quality records, including Clinical Study Reports, Trial Master Files, Device History Records, Deviations, OOS reports, audit reports, Research and Development protocols and reports, and Software validation protocols and reports.

    Conduct audits of GCP, GLP, and GMP suppliers and service providers, including CAPA assessment and follow-up.

    Manage activities for registration readiness by interpreting regulations and developing procedures for ISO, CE marking, and other international requirements, including readiness of vendors, suppliers, CMOs, and laboratories.

    Oversee change controls, complaints, investigations, CAPAs, IQ/OQ/PQ protocols and reports, specifications, and stability protocols to ensure compliance with regulatory requirements (FDA/ICH/ISO).

    Review and approve lot analytical methods, method validation protocols and reports, and stability protocols.

    Conduct final product lot and clinical trial supplies disposition activities, ensuring compliance with cGMPs, company SOPs, policies, and specifications.

    This role requires a seasoned professional with a proven track record in quality assurance for medical devices and combination products, capable of managing complex quality systems and driving continuous improvement. The ideal candidate will have extensive experience in quality compliance, regulatory requirements, and leading quality investigations.


  • Marcum LLP

    Assurance Manager

    4 days ago


    Marcum LLP Boston, United States

    Assurance Manager - Boston page is loaded · Assurance Manager - Boston · Apply · locations · Boston, MA · time type · Full time · posted on · Posted 4 Days Ago · job requisition id · R4227 · Marcum LLP offers a great career with exceptional benefits. · There's a lot to ...

  • Marcum LLP

    Assurance Manager

    3 weeks ago


    Marcum LLP Boston, United States

    Marcum LLP offers a great career with exceptional benefits. · There's a lot to think about when it comes to launching your career. At Marcum, we offer you a world of opportunity, a highly competitive salary, exceptional benefits, flexible work options, and industry-leading techno ...

  • Marcum Search

    Assurance Manager

    5 days ago


    Marcum Search Boston, United States

    Marcum LLP offers a great career with exceptional benefits. · There's a lot to think about when it comes to launching your career. At Marcum, we offer you a world of opportunity, a highly competitive salary, exceptional benefits, flexible work options, and industry-leading techn ...


  • Veritas Search Group Boston, United States

    Senior Manager, Quality Assurance (Med Device / Combination Products) · Location: Fully Remote · Scope of Work: · The Senior Manager, Quality Assurance (Med Device / Combination Products) will be responsible for ensuring compliance with quality standards for pharmaceuticals, medi ...


  • CliftonLarsonAllen Boston, United States

    CLA is a top 10 national professional services firm where our purpose is to create opportunities every day, for our clients, our people, and our communities through industry-focused wealth advisory, digital, audit, tax, consulting, and outsourcing services. Even with more than 8, ...


  • Marcum LLP Boston, United States

    Marcum LLP offers a great career with exceptional benefits. · There's a lot to think about when it comes to launching your career. At Marcum, we offer you a world of opportunity, a highly competitive salary, exceptional benefits, flexible work options, and industry-leading techno ...


  • Marcum Search Boston, United States

    Marcum LLP offers a great career with exceptional benefits. · There's a lot to think about when it comes to launching your accounting career. At Marcum, we offer you a world of opportunity, a highly competitive salary, exceptional benefits, flexible work options, and industry-le ...


  • CohnReznick Boston, United States

    Opportunity ID · 7182 · Department(s) · Assurance · Location(s) · Boston · Function · Audit · Job description · As CohnReznick grows, so do our career opportunities. As one of the nation's top Professional Services and Business Advisory firms, we foster teams in Advisory, Assuran ...


  • RADCUBE | Rapid Technology Solutions Boston, United States

    Primary Responsibilities · • Lead test strategy, balancing priorities such as test coverage, test quality, competing demands, and project schedule. · • Track, measure, and report on progress identifying, writing, and executing tests, and resolving defects. · • Identify systemic p ...

  • Marcum LLP

    Assurance Manager

    1 week ago


    Marcum LLP Boston, United States

    Marcum LLP offers a great career with exceptional benefits. · There's a lot to think about when it comes to launching your career. At Marcum, we offer you a world of opportunity, a highly competitive salary, exceptional benefits, flexible work options, and industry-leading techno ...


  • Community Phone Boston, United States

    [Full Time] Quality Assurance Operations Manager at Community Phone Company (United States) | BEAMSTART Jobs · Quality Assurance Operations Manager · Community Phone Company United States · Date Posted · 31 Oct, 2022 · Work Location · Boston, United States · Salary Offered · $4 ...


  • NavitsPartners Boston, United States

    Job Description · Job Description · Position: · Quality Assurance Test Manager · Duration: · 18-24 months · Hours Per Week: · 37.5 · Location: · Hybrid (Boston, MA) · Position Summary: · The QA Test Manager plays a critical role in ensuring the quality and compliance of the ...


  • Commonwealth Care Alliance Boston, United States

    Why This Role is Important to Us · The Senior Manager, IT Quality Assurance is part of the Business Solutions team responsible for QA testing, product management and solutions delivery. This role is the primary owner for the QA Managed Services program and will be critical in th ...


  • Dice Boston, United States

    Dice is the leading career destination for tech experts at every stage of their careers. Our client, Motion Recruitment Partners, LLC, is seeking the following. Apply via Dice today · Our Client, an independent agency who oversee financial systems as well as manage external sing ...


  • Commonwealth Care Alliance Boston, United States

    **Why This Role is Important to Us:** · The Senior Manager, IT Quality Assurance is part of the Business Solutions team responsible for QA testing, product management and solutions delivery. This role is the primary owner for the QA Managed Services program and will be critical ...


  • Talnt LLC Boston, United States

    About the job Senior Supplier Quality Assurance Manager · Responsibilities: · Manage systems and processes to oversee supplier quality, including handling the supplier change control system, supplier investigations, and supplier validation activities. · Oversee combination pro ...


  • Apex Systems Boston, United States

    Apex Systems is a world class technology services business that incorporates industry insights and experience to deliver solutions that fulfill our clients' digital visions. Apex has an opportunity for a DOL Quality Assurance Test Manager . For applicants who are interested in th ...


  • JobRialto Boston, United States

    Job Summary:The Salesforce Quality Assurance (QA) Lead supports the Agency working as a member of the Technology, Analytics and Digital Transformation ("Technology") team. The Salesforce QA Lead is responsible for assessing overall Salesforce system risk, creating a test harness ...


  • Compass Group USA Boston, United States

    QUALITY ASSURANCE MANAGERClick Here to Apply OnlineJob Description Restaurant Associates Salary: $70,500 - $138,500Other Forms of Compensation: Become part of Restaurant Associates, the industry's leading provider of dining and event catering for some of the nation's most prestig ...


  • Marcum LLP Boston, United States

    Assurance Senior Manager - Boston page is loaded · Assurance Senior Manager - Boston · Apply · locations · Boston, MA · time type · Full time · posted on · Posted 2 Days Ago · job requisition id · R3789 · Marcum LLP offers a great career with exceptional benefits. · Th ...