Jobs
>
Bridgewater

    Vice President Regulatory Affairs Quality Assurance - Bridgewater, United States - EPM Scientific

    EPM Scientific
    EPM Scientific Bridgewater, United States

    3 weeks ago

    Default job background
    Description

    Responsibilities:
    Lead the development and execution of regulatory strategies for PMA submissions, ensuring alignment with company goals and regulatory requirements.
    Oversee the preparation, review, and submission of PMA applications to regulatory authorities, including the FDA.
    Provide guidance and expertise on regulatory requirements, standards, and best practices related to PMA submissions.
    Collaborate with cross-functional teams to gather and compile necessary data and documentation for PMA submissions.
    Ensure compliance with regulatory requirements and standards throughout the PMA process, from pre-submission to post-approval activities.
    Manage interactions with regulatory agencies and represent the company in PMA-related meetings and communications.
    Establish and maintain a robust quality management system (QMS) to support PMA submissions and ongoing compliance.
    Lead quality assurance initiatives to maintain high standards of product quality and safety throughout the PMA process.
    Provide leadership, mentorship, and development opportunities for the regulatory affairs and quality assurance teams.

    Qualifications:
    Bachelor's degree in a scientific or engineering discipline; advanced degree preferred.
    Minimum of 12 years of experience in regulatory affairs and quality assurance within the medical device industry.
    Proven track record of successful PMA submissions and approvals for medical devices.
    Thorough understanding of FDA regulations, guidance documents, and PMA requirements.
    Strong leadership skills with the ability to drive results and foster a culture of compliance and quality.
    Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
    Strategic thinker with the ability to develop innovative regulatory strategies and solutions.

    #J-18808-Ljbffr
  • EKS Solutions

    Quality Assurance

    1 week ago

    EKS Solutions Providence, United States

    **Benefits**: · - 401(k) · - Bonus based on performance · - Competitive salary · - Opportunity for advancement · - Training & development · We are seeking a meticulous and detail-oriented individual to join our team as a Quality Assurance Food GMP Specialist. In this role, you wi ...

  • Concord Foods LLC

    Plant Quality Assurance Manager

    3 days ago

    Concord Foods LLC Brockton, United States

    Concord Foods is looking for a Plant Quality Assurance Manager to join our team · **Responsibilities include but not limited to....** · - Support the implementation and execution of the company's quality system programs. · - Drive Process Improvements in the processing areas. · - ...

  • Element2 Group

    Quality Assurance Supervisor

    3 weeks ago

    Element2 Group Fall River, United States

    **Job Overview**: · We are seeking a highly skilled and experienced Quality Assurance Supervisor to join our team. As the Quality Assurance Sueprvisor, you will be responsible for ensuring that our products meet the highest quality standards and comply with all relevant regulatio ...

  • Element2 Group

    Quality Assurance Inspector

    3 weeks ago

    Element2 Group Providence, United States

    **We are hiring for 3rd shift Quality Inspectors - 10:45pm - 7:15am** · - **MUST**_ have experience performing quality inspections and using measuring tool such as micrometers, calipers etc., · Available to interview immediately · **Overview**: · We are seeking a detail-oriented ...

  • Element2 Group

    Quality Assurance Inspector

    3 weeks ago

    Element2 Group East Providence, United States

    **We are hiring for 3rd shift Quality Inspectors for our manufacturing facility** · **Shift - 11pm - 7:30am** · **Pay - $20-$21/hr depending on experience.** · **Available to interview and start ASAP** · **Responsibilities**: · - Perform inspections on incoming materials, in-proc ...

  • Ultra Electronics

    Quality Assurance Technician

    3 weeks ago

    Ultra Electronics Braintree, United States

    Unleash the Power of Multi-Mission Excellence: Safeguarding the Seas for the World's Navies. · Step into a world where cutting-edge technology meets unparalleled expertise. Ultra Maritime pioneers delivering multi-mission solutions that protect and empower the naval forces worldw ...

  • Luxury Brand Holdings

    Quality Assurance Specialist

    2 weeks ago

    Luxury Brand Holdings Cranston, United States

    America's Favorite Jeweler, Ross-Simons (a division of Luxury Brand Holdings), is seeking a Quality Assurance Specialist based in our Cranston, RI office. This position is responsible for assisting the Gemology Department with managing the Quality Tracking Database and inspecting ...

  • State of Rhode Island

    Quality Assurance Investigator

    2 weeks ago

    State of Rhode Island Cranston, United States

    **Class Definition**: · **GENERAL STATEMENT OF DUTIES**:Within the Department of Behavioral Healthcare, Developmental Disabilities and Hospitals (BHDDH), to perform investigative duties and crisis intervention services for adult victims with severe impairments of abuse, neglect a ...

  • MES Solutions, Inc.

    Quality Assurance Coordinator

    3 weeks ago

    MES Solutions, Inc. Norwood, United States

    Overview: · Are you a Medical Scribe who prides yourself on your strong writing/grammar abilities? Are you also looking to step away from a medical office and into a work-from-home position? · If you answered yes, then this might be the job for you because **MES **is looking for ...

  • DPS Group

    Quality Assurance Specialist

    3 weeks ago

    DPS Group Boston, United States

    ADPS Group is seeking a Quality Assurance Specialist to support leading and owning risk assessments in support of change controls and deviations. The scope of work will require writing risk assessment documents and holding stakeholder meetings to progress risk assessments and obt ...

  • DPS Group TSO

    Quality Assurance Specialist

    3 weeks ago

    DPS Group TSO Boston, United States

    **Summary** · ADPS Group is seeking a Quality Assurance Specialist to support leading and owning risk assessments in support of change controls and deviations. The scope of work will require writing risk assessment documents and holding stakeholder meetings to progress risk asses ...

  • Affinity Executive Search

    Quality Assurance Manager

    6 days ago

    Affinity Executive Search Bridgewater, United States

    Global Pharmaceutical company, with US HQ in Central New Jersey, focused in Metabolics, Endocrinology and Oncology is expanding · Looking for a strong Quality Assurance Manager for the entire North American manufacturing and quality organization. · Managing and supporting Good ...

  • Skyline Solutions

    Quality Assurance Specialist

    2 days ago

    Skyline Solutions Greenville, RI, United States Freelance

    For our location in **Greenville, RI (near Regensburg / Neumarkt in der Oberpfalz)**, we are currently looking for a **Quality Assurance Specialist (m/f/d)** to start immediately or at the earliest possible date. · **Your responsibilities**: · - Coordination of rework/sorting act ...

  • Deephealth

    Quality Assurance Specialist

    1 week ago

    Deephealth Somerville, United States

    **Job Description**: · Artificial Intelligence; Advanced Technology; The very best in patient care. With decades of expertise, RadNet is _Leading Radiology Forward_. With dynamic cross-training and advancement opportunities in a team-focused environment, the core of RadNet's succ ...

  • Sapphire Enterprises

    Quality Assurance Manager

    3 weeks ago

    Sapphire Enterprises Fall City, United States

    We are a rapidly growing supplier of tube-based components for the international automotive industry. We are currently seeking a qualified Quality Assurance Manager (m/f/d) to join our team at our Fall City location (Address: STC GmbH, Röhre 54-56, 59846 Fall City) as soon as pos ...

  • Elegant Enterprise Wide Solutions, Inc

    Quality Assurance Lead

    4 days ago

    Elegant Enterprise Wide Solutions, Inc Boston, United States

    **Minimum Requirements** · - Five (5) years of experience in quality assurance, vendor management, and/or technology design/testing/implementation/operation. · - Experience with developing, implementing and/or overseeing test plans and test reports. · - Effective organizational, ...

  • Elegant Enterprise Wide Solutions, Inc

    Quality Assurance Lead

    2 days ago

    Elegant Enterprise Wide Solutions, Inc Boston, United States

    **Minimum Requirements** · - Five (5) years of experience in quality assurance, vendor management, and/or technology design/testing/implementation/operation. · - Experience with developing, implementing and/or overseeing test plans and test reports. · - Effective organizational, ...

  • RADcube

    Quality Assurance Manager

    13 hours ago

    RADcube Boston, United States

    **Quality Assurance Manager**: · **Type**:Contract | **Location**:Boston, Massachusetts · Primary Responsibilities · - Lead test strategy, balancing priorities such as test coverage, test quality, competing demands, and project schedule. · - Track, measure, and report on progress ...

  • Moderna

    Specialist, Quality Assurance

    2 days ago

    Moderna Norwood, United States

    **The Role**: · The Quality Assurance Specialist is part of a cohesive team responsible for supporting cGMP oversight of internal manufacturing at Moderna Inc. · **Here's What You'll Do**: · Provides on-the-floor Quality support to Manufacturing. Makes quality decisions and/or es ...

  • AAA Northeast

    Quality Assurance Analyst I

    2 weeks ago

    AAA Northeast Providence, United States

    The Quality Assurance Specialist is the critical front-end member voice for eBusiness, working cross-functionally and responsible for the creation and execution of test cases, and management of issues discovered during the testing process. The Quality Assurance Specialist will al ...