Jobs
>
North Tonawanda

    Manager, Quality Assurance - North Tonawanda, United States - The Cooper Companies

    The Cooper Companies
    The Cooper Companies North Tonawanda, United States

    1 week ago

    Default job background
    Description
    About CooperSurgical

    CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life.

    CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families.

    We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.
    CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO).

    CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians.

    More information can be found at

    CSI believes the quality, safety, and efficacy of our products are of the utmost importance to ensure we deliver impactful solutions that improve healthcare.

    The Quality Assurance Manager will be responsible for ensuring all products manufactured at the site are manufactured in accordance with appropriate Federal, State & Local regulatory and governing bodies.

    Serve as the site head of quality assurance and the management representative at the North Tonawanda, NY manufacturing site.

    • Manage, maintain, and continuously improve the quality management system at the site level.
    • Provide site quality leadership to the following, but not limited to, quality systems lifecycle maintenance, raw material and final product release, supply chain, automation, manufacturing, validation, product quality complaints, deviations, corrective and preventative actions (CAPAs), and facility engineering.
    • Establish, approve, and execute quality procedures to support commercial cGMP production at the site.
    • Oversee and manage the execution of quality systems during daily production activities to ensure the delivery of high-quality products.
    • Lead the preparation and execution of both internal and external audits and serve as the host for regulatory audits/inspections at the site. Job Description
    • Maintain Key Performance Indicators and Quality Metrics at the site and present the data to Operations and Senior Quality Leadership on a monthly basis.
    • Manage quality assurance personnel and when necessary, recruit, train, and develop quality assurance personnel to meet applicable cGMP compliance requirements and business objectives.
    • Manage vendors for any outsourced activities and suppliers for the site and audit the vendors and suppliers as required.
    • Represent the site and CooperSurgical at any events, conventions, seminars, trainings, etc. held outside of CooperSurgical facilities.
    • Bachelor's degree in a health or science field required; Advanced degree preferred.
    • Minimum of 10 years of experience in pharmaceutical or healthcare industry related experience, 3-5 years of quality assurance management experience, minimum of 5 years of supervisory experience.
    • Must have working knowledge of current Good Manufacturing Practices (cGMP), FDA regulations and guidance, and 21 CFR 210, 211, and 820.
    • Ability to work with a multidisciplinary team and establish working relationships both internally and externally.
    • Must be proficient in the use of Microsoft Excel, Microsoft Word, Outlook, and PowerPoint.
    • Experience in hosting regulatory audits/inspections is preferred.
    • Ability to read, understand, and write highly technical material.
    • Proficient in reading, writing, and communicating in the English language.
    As an employee of CooperSurgical, you'll receive an outstanding total compensation plan.

    As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits.

    Please visit us at to learn more about CooperSurgical and the benefits of becoming a member of our team.


    To all agencies:
    Please, no phone calls or emails to any employee of CooperSurgical about this opening.

    All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place.

    In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.

    We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status.

    We are proud to be an equal opportunity workplace.

    #J-18808-Ljbffr
  • a Medical Devices equipment company located in New York

    Quality Assurance Manager

    1 week ago

    a Medical Devices equipment company located in New York North Tonawanda, United States

    Quality Assurance Manager · RESPONSIBILITIES · Ensuring compliance with all Federal, State & Local regulatory requirements for products manufactured at the New York site. · Act as the Quality Assurance lead and management representative for the site. · Manage and enhance the qual ...

  • a Medical Devices equipment company located in New York

    Quality Assurance Manager

    3 days ago

    a Medical Devices equipment company located in New York North Tonawanda, United States

    Quality Assurance Manager · Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants. · RESPONSIBILITIESEnsuring compliance with all Federal, State & Local regulatory requirements for products manufactured at the ...

  • a Medical Devices equipment company located in New York

    Quality Assurance Manager

    1 week ago

    a Medical Devices equipment company located in New York North Tonawanda, United States

    Quality Assurance Manager · RESPONSIBILITIES · Ensuring compliance with all Federal, State & Local regulatory requirements for products manufactured at the New York site. · Act as the Quality Assurance lead and management representative for the site. · Manage and enhance the ...

  • Cooper Companies

    Manager, Quality Assurance

    6 days ago

    Cooper Companies North Tonawanda, United States

    Job Description · About CooperSurgical · CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of deliverin ...

  • a Medical Devices equipment company located in New York

    Quality Assurance Manager

    1 week ago

    a Medical Devices equipment company located in New York Tonawanda, United States

    Quality Assurance Manager · Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants. · RESPONSIBILITIES · Ensuring compliance with all Federal, State & Local regulatory requirements for products manufactured at ...

  • DIMAR MANUFACTURING

    Quality Assurance Technician

    1 week ago

    DIMAR MANUFACTURING Cheektowaga, NY, US, United States

    :Clarence, NY 14031 · *Must have reliable transportation* · Pay Rate: $19-24/hour · **Sign-On Bonus $1200** · After the completion of one year of service. · Job Summary for Quality Assurance Technician: · The Quality Assurance Technician level 1 performs dimensional and/or functi ...

  • DIMAR MANUFACTURING

    Quality Assurance Technician

    1 week ago

    DIMAR MANUFACTURING Cheektowaga, NY, US, United States

    :Clarence, NY 14031 · *Must have reliable transportation* · Pay Rate: $19-24/hour · **Sign-On Bonus $1200** · After the completion of one year of service. · Job Summary for Quality Assurance Technician: · The Quality Assurance Technician level 1 performs dimensional and/or functi ...

  • DIMAR MANUFACTURING

    Quality Assurance Technician

    1 week ago

    DIMAR MANUFACTURING Cheektowaga, NY, US, United States

    Clarence, NY 14031 · *Must have reliable transportation* · Pay Rate: $19-24/hour · **Sign-On Bonus $1200** · After the completion of one year of service. · Job Summary for Quality Assurance Technician: · The Quality Assurance Technician level 1 performs dimensional and/or functio ...

  • DIMAR MANUFACTURING

    Quality Assurance Technician

    2 weeks ago

    DIMAR MANUFACTURING Cheektowaga, NY, US, United States Full time

    :Clarence, NY 14031 · *Must have reliable transportation* · Pay Rate: $19-24/hour · **Sign-On Bonus $1200** · After the completion of one year of service. · Job Summary for Quality Assurance Technician: · The Quality Assurance Technician level 1 performs dimensional and/or functi ...

  • DIMAR MANUFACTURING

    Quality Assurance Technician

    1 week ago

    DIMAR MANUFACTURING Cheektowaga, NY, US, United States

    Clarence, NY 14031 · *Must have reliable transportation* · Pay Rate: $19-24/hour · **Sign-On Bonus $1200** · After the completion of one year of service. · Job Summary for Quality Assurance Technician: · The Quality Assurance Technician level 1 performs dimensional and/or functio ...

  • DIMAR MANUFACTURING

    Quality Assurance Technician

    1 week ago

    DIMAR MANUFACTURING Cheektowaga, NY, US, United States

    :Clarence, NY 14031 · *Must have reliable transportation* · Pay Rate: $19-24/hour · **Sign-On Bonus $1200** · After the completion of one year of service. · Job Summary for Quality Assurance Technician: · The Quality Assurance Technician level 1 performs dimensional and/or functi ...

  • DIMAR MANUFACTURING

    Quality Assurance Technician

    1 week ago

    DIMAR MANUFACTURING Cheektowaga, United States

    :Clarence, NY 14031 · *Must have reliable transportation* · Pay Rate: $19-24/hour · **Sign-On Bonus $1200** · After the completion of one year of service. · Job Summary for Quality Assurance Technician: · The Quality Assurance Technician level 1 performs dimensional and/or functi ...

  • DIMAR MANUFACTURING

    Quality Assurance Technician

    1 week ago

    DIMAR MANUFACTURING Cheektowaga, United States

    :Clarence, NY 14031 · *Must have reliable transportation* · Pay Rate: $19-24/hour · **Sign-On Bonus $1200** · After the completion of one year of service. · Job Summary for Quality Assurance Technician: · The Quality Assurance Technician level 1 performs dimensional and/or functi ...

  • DIMAR MANUFACTURING

    Quality Assurance Technician

    2 weeks ago

    DIMAR MANUFACTURING Cheektowaga, United States

    :Clarence, NY 14031 · *Must have reliable transportation* · Pay Rate: $19-24/hour · **Sign-On Bonus $1200** · After the completion of one year of service. · Job Summary for Quality Assurance Technician: · The Quality Assurance Technician level 1 performs dimensional and/or functi ...

  • DIMAR MANUFACTURING

    Quality Assurance Technician

    1 week ago

    DIMAR MANUFACTURING Cheektowaga, United States

    :Clarence, NY 14031 · *Must have reliable transportation* · Pay Rate: $19-24/hour · **Sign-On Bonus $1200** · After the completion of one year of service. · Job Summary for Quality Assurance Technician: · The Quality Assurance Technician level 1 performs dimensional and/or functi ...

  • DIMAR MANUFACTURING

    Quality Assurance Technician

    1 week ago

    DIMAR MANUFACTURING Cheektowaga, United States

    Clarence, NY 14031 · *Must have reliable transportation* · Pay Rate: $19-24/hour · **Sign-On Bonus $1200** · After the completion of one year of service. · Job Summary for Quality Assurance Technician: · The Quality Assurance Technician level 1 performs dimensional and/or functio ...

  • DIMAR MANUFACTURING

    Quality Assurance Technician Nights

    3 weeks ago

    DIMAR MANUFACTURING Cheektowaga, NY, United States

    : · Clarence, NY 14031 · *Must have reliable transportation* · Pay Rate: $19-24/hour · **Sign-On Bonus $1200** · After the completion of one year of service. · Job Summary for Quality Assurance Technician: · The Quality Assurance Technician level 1 performs dimensional and/or ...

  • DIMAR MANUFACTURING

    Quality Assurance Technician Nights

    1 week ago

    DIMAR MANUFACTURING Cheektowaga, NY, United States

    : · Clarence, NY 14031 · *Must have reliable transportation* · Pay Rate: $19-24/hour · **Sign-On Bonus $1200** · After the completion of one year of service. · Job Summary for Quality Assurance Technician: · The Quality Assurance Technician level 1 performs dimensional and/or ...

  • M&T Bank

    Quality Assurance Analyst I

    6 days ago

    M&T Bank Getzville, United States

    Overview: · Monitors and/or completes audits of activities of a more basic nature within an assigned area of the Bank to ensure adherence to internal policies, processes and external regulations. Communicates findings to appropriate parties to mitigate recurring issues of the sam ...

  • Construction Trade Staffing, Inc.

    Quality Assurance

    1 week ago

    Construction Trade Staffing, Inc. Orchard Park, United States

    The QC Inspector is responsible for the inspection of incoming parts from suppliers and those machined in-house, to the print specifications furnished by engineering through the use of the following tools: calipers, micrometers, bore gages, super-mics, comparator, hardness tester ...