Quality Assurance Director jobs in Maine

Quality Assurance Director is responsible for the implementation of policies and procedures to ensure adherence to production quality standards. Monitors and audits process, material, and product testing against established standards and conducts a continuous analysis of quality defects and deviations. Being a Quality Assurance Director identifies deficiencies or gaps in testing activities and develops solutions to ensure adequate and robust quality processes. Optimizes processes to comply with existing and new regulatory requirements. Additionally, Quality Assurance Director typically requires a bachelor's degree. Typically reports to a director. The Quality Assurance Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Quality Assurance Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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Quality Assurance
  • Maine Molecular Quality Controls, Inc
  • Saco, ME FULL_TIME
  • Quality Assurance/Regulatory Affairs Specialist I: Molecular Diagnostic Products

    Employer: Maine Molecular Quality Controls, Inc. (MMQCI) designs, develops, manufactures, and markets unique quality control products used by hospital laboratories to monitor the accuracy of tests for inherited disease, pharmacogenetics, oncology, and infectious diseases. MMQCI has developed technologies to stabilize DNA and RNA for use as quality controls and continues to pursue the discovery of novel techniques useful for the development of new quality control products. We are a small, growing company that offers a relaxed but challenging work environment.

    POSITION TITLE: Quality Assurance/Regulatory Affairs Specialist I

    BENEFITS:

    • Medical insurance
    • Dental insurance
    • 401(k)
    • Profit sharing plan
    • Vacation
    • Holidays
    • Sick leave

    How to apply: by Email/ No Phone inquiries accepted

    A cover letter is required.

    GENERAL SUMMARY:

    The Quality Assurance/Regulatory Affairs Specialist I is responsible for activities involving quality assurance and compliance with applicable regulatory requirements. Under the supervision of the Manager of QA/RA, the QA/RA Specialist I is responsible for the maintenance of policies, and management of procedures, that ensure quality compliance to MMQCI’s Quality System, based on federal Quality System Regulation 21CFR820. The successful candidate is experienced in using and maintaining a Quality System according to 21CFR820. It is expected that the QA/RA Specialist I will rapidly develop sufficient expertise to function independently. Maine Molecular is looking for the person with the energy and experience to step into this vital position in a growing company and grow along with us.

    PRINCIPAL DUTIES AND RESPONSIBILITIES:

    • Maintains MMQCI Quality System documentation to ensure compliance with established procedures and regulatory compliance requirements, including, but not limited to, Standard Operating Procedures (SOPs), Master Batch Records, Change Orders, Material Review Notices (MRNs) and Corrective and Preventive Actions (CAPAs).
    • Assists or performs internal audits and supplier audits.
    • Supports FDA, ISO, and customer audits.
    • Assists in the assembly Device Master Records for new products.
    • Maintains training documentation of all MMQCI employees.

    MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

    • Education Requirements: Bachelor of Science degree in Life Sciences and at least 5 years of employment in a cGMP regulated facility and at least 2 years of experience in Quality Assurance.
    • Good communication skills, written and oral, with excellent computer skills.
    • Excellent proof-reading skills are required.
    • Very detail oriented.
    • Knowledge of current GMP regulations is required.
    • Knowledge of ISO 13485 is preferred.
    • Experience in laboratory medicine is highly preferred.
    • A strong work ethic with the ability to work in a dynamic environment with changing priorities.
    • Ability to meet challenging timelines, in spite of obstacles.
    • Willingness to learn and pitch in as part of team
    • Ability to communicate clearly and constructively to correct non-conforming behaviors and practices.
    • Must be a nonsmoker due to product contamination prevention requirements.

    A cover letter is required.

    Contact Information:

    Human Resources

    Maine Molecular Quality Controls, Inc.

    23 Mill Brook Road

    Saco, Maine 04072

    LOCATION: MMQCI is conveniently located in beautiful southern coastal Maine, minutes from the Maine Turnpike, Portland International Jetport, and less than 2 hours from Boston. Close by are fabulous Portland restaurants, sandy beaches, and a plentiful supply of Maine lobsters! Many terrific outdoor activities are easily accessible including hiking, biking, kayaking, fishing, skiing and snowshoeing. We have a beautiful, state-of-the-art facility located in Saco, right next to the Eastern Trail. Come join us!

    Job Type: Full-time

    Benefits:

    • 401(k)
    • Dental insurance
    • Health insurance
    • Paid time off
    • Parental leave

    Schedule:

    • 8 hour shift
    • Monday to Friday

    Education:

    • Bachelor's (Required)

    Experience:

    • Quality Assurance: 2 years (Preferred)
    • ISO 13485: 1 year (Preferred)
    • Laboratory: 1 year (Preferred)
    • cGMP: 5 years (Preferred)

    Work Location: In person

  • 1 Month Ago

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Quality Assurance/Regulatory Affairs Associate
  • Maine Molecular Quality Controls, Inc
  • Saco, ME FULL_TIME
  • Quality Assurance/Regulatory Affairs Associate Employer: Maine Molecular Quality Controls, Inc. (MMQCI) designs, develops, manufactures, and markets unique quality control products used by hospital la...
  • 1 Month Ago

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Quality Assurance Engineer
  • Axway Software SA
  • Cornish, ME FULL_TIME
  • Overview In 2024, we are pursuing our ambitions to continue to enable organizations' digital transformation. We are looking for our new Quality Engineer to join Axway's family. Are you ready? Join us ...
  • 18 Days Ago

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Quality Assurance Officer
  • Public Consulting Group
  • Augusta, ME OTHER
  • Overview Staffing Solutions Organization LLC (SSO), an affiliate of Public Consulting Group LLC (PCG), is focused on delighting clients with world-class managed staffing and talent consulting services...
  • 20 Days Ago

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Quality Assurance Specialist
  • Precision Optics Corporation Inc
  • Windham, ME FULL_TIME
  • Job Description Job Description Description : Overview Overview Responsible for performing incoming and outgoing inspections as well as maintaining the electronic documentation system / recordkeeping ...
  • 23 Days Ago

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Training and Quality Assurance Coordinator
  • VOA Northern New England
  • Bangor, ME FULL_TIME
  • Are you looking for a job opportunity that allows you to experience the joy of serving others? If so, then we are the company for you! Volunteers of America serves people and communities in need and m...
  • 23 Days Ago

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Quality Assurance Director
  • The Judge Group
  • Hanover, PA
  • JDP is seeking a Director of Quality Assurance in Hanover, PA area! The candidate will be responsible for establishing a...
  • 3/28/2024 12:00:00 AM

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Quality Assurance Director (Nutraceuticals)
  • Gummi World
  • Chandler, AZ
  • Gummi World is a fast-growing nutraceutical manufacturer based in Chandler, Arizona. We strive to deliver the highest qu...
  • 3/28/2024 12:00:00 AM

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Associate Director of Quality Assurance, Plum
  • Sun-Maid Growers of California
  • Fresno, CA
  • This role will lead our contract manufacturing and ingredient suppliers for Plum, PBC (Plum). The Associate Director of ...
  • 3/28/2024 12:00:00 AM

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Director, Radiology Quality Assurance Program
  • Partners Healthcare System
  • Somerville, MA
  • About Us As a not-for-profit organization, Partners HealthCare is committed to supporting patient care, research, teachi...
  • 3/28/2024 12:00:00 AM

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Regional Director of Quality Assurance
  • Agape Care Group
  • Spartanburg, SC
  • Overview: Join Our Team as a Regional Director of Quality Assurance - RN Is it important to you that patients receive sa...
  • 3/27/2024 12:00:00 AM

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Director of Quality Assurance
  • Envision Unlimited
  • Chicago, IL
  • Job Description Job Description The Director of Quality Assurance is responsible for overseeing and implementing quality...
  • 3/26/2024 12:00:00 AM

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Director of Quality Assurance
  • Skills Alliance
  • Fort Lauderdale, FL
  • I am working exclusively with a client looking to hire a Director QA to support their team. The successful candidate mus...
  • 3/24/2024 12:00:00 AM

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Quality Assurance Director
  • Conceal
  • Augusta, GA
  • Job Description Job Description As a Quality Assurance Director (QA Director), you will oversee the software quality con...
  • 3/24/2024 12:00:00 AM

To the south and east is the Atlantic Ocean and to the north and northeast is New Brunswick, a province of Canada. The Canadian province of Quebec is to the northwest. Maine is both the northernmost state in New England and the largest, accounting for almost half of the region's entire land area. Maine is the only state in the continental US to border only one other American state (New Hampshire to the South and West). Maine is the easternmost state in the United States in both its extreme points and its geographic center. The town of Lubec is the easternmost organized settlement in the United...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Quality Assurance Director jobs
$154,978 to $195,484

Quality Assurance Director in Racine, WI
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Quality assurance assistants perform many tasks to accomplish their core goal.
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