QUALITY ASSURANCE MANAGER jobs in Portland, ME

QUALITY ASSURANCE MANAGER 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 MANAGER 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 MANAGER typically requires a bachelor's degree. Typically reports to a director. The QUALITY ASSURANCE MANAGER manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a QUALITY ASSURANCE MANAGER typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (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 Manager
  • Robert Half
  • Fort Worth, TX PER_DIEM
  • Position Overview: The role of a Quality Control Lab Supervisor involves overseeing vital quality control aspects, from developing schedules to collaborating with your team on critical documentation. ...
  • 2 Days 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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Commercial Insurance Quality Assurance Account Manager
  • Alexander & Schmidt
  • Yarmouth, ME FULL_TIME
  • The Quality Assurance Account Manager is the primary point of contact for assigned accounts. The QA Account Manager is the recognized expert for technical content and specific requirements for the cli...
  • 4 Days Ago

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Manager - Coding Audit Education and Quality Assurance
  • MaineHealth
  • Scarborough, ME FULL_TIME
  • Summary Position Summary **Fully remote flexible hours! The Coding Audit Education and Quality Assurance Manager manages a team of DRG Validation Specialist/Educators, Outpatient Quality Compliance au...
  • 13 Days Ago

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Section Manager, Lifecycle Quality Assurance, Engineering
  • General Dynamics - Bath Iron Works
  • Brunswick, ME FULL_TIME
  • Job Description The Section Manager of Lifecycle Quality Assurance reports to the Director of Lifecycle Engineering and is responsible for leading a team of quality and training specialists to develop...
  • Just Posted

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0 QUALITY ASSURANCE MANAGER jobs found in Portland, ME area

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Assistant Manager - Scarborough, ME
  • Goodyear
  • Scarborough, ME
  • ** Assistant Manager - Scarborough, ME** Date: Sep 9, 2021 Location: Scarborough, ME, US, 04074 Company: Goodyear Job Re...
  • 3/28/2024 12:00:00 AM

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Program Coordinator-MaineHealth Institute for Research
  • Maine Health
  • Westbrook, ME
  • Full Time 1 Riverfront Plaza Professional - Nonclinical Day Shift * Position Summary * This Program Coordinator performs...
  • 3/28/2024 12:00:00 AM

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Surgical Scheduler-Urology
  • Maine Health
  • South Portland, ME
  • Full Time 100 Brickhill Avenue Clerical/Administrative Support Day Shift Position Summary Position is responsible for pe...
  • 3/28/2024 12:00:00 AM

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Buyer
  • The Judge Group
  • Sanford, ME
  • JOB SUMMARYWe are seeking a qualified individual for the role of Buyer, who will be responsible for various procurement ...
  • 3/28/2024 12:00:00 AM

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Supply Chain Associate/Warehouse Worker (1st Shift)
  • IDEXX Laboratories, Inc.
  • Westbrook, ME
  • **Supply Chain Associate/Warehouse Worker (1st Shift)** Westbrook, ME Operations As a **Supply Chain Associate** in IDEX...
  • 3/28/2024 12:00:00 AM

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Warehouse Associate
  • IDEXX Laboratories, Inc.
  • Westbrook, ME
  • As a Warehouse Associate in IDEXX's Westbrook distribution center, you may perform a variety of tasks including receivin...
  • 3/26/2024 12:00:00 AM

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Director of Human Resources
  • Group Main Stream
  • Westbrook, ME
  • Job Description Job Description The Director of Human Resources is responsible for the overall administration, coordinat...
  • 3/24/2024 12:00:00 AM

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Patient Service Representative - Family Medicine
  • Maine Health
  • Portland, ME
  • Part Time 277 Congress Street Clerical/Administrative Support Day/Evening Maine Medical Partners - Portland Family Medic...
  • 3/24/2024 12:00:00 AM

Portland is a city in the U.S. state of Maine, with a population of 67,067 as of 2017. The Greater Portland metropolitan area is home to over half a million people, more than one-third of Maine's total population, making it the most populous metro in northern New England (an area comprising the states of Maine, New Hampshire, and Vermont). Portland is Maine's economic center, with an economy that relies on the service sector and tourism. The Old Port district is known for its 19th-century architecture and nightlife. Marine industry still plays an important role in the city's economy, with an a...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for QUALITY ASSURANCE MANAGER jobs
$117,241 to $153,247
Portland, Maine area prices
were up 1.6% from a year ago

QUALITY ASSURANCE MANAGER in Juneau, AK
Whatever type of industry you work in, be it retail, health care, software, manufacturing or another industry, chances are that a quality assurance manager helps your business meet and exceed quality-control standards for your services and products.
December 23, 2019
QUALITY ASSURANCE MANAGER in Great Falls, MT
In larger companies, quality assurance managers usually lead an entire department or sector, and they hire employees as part of their duties.
February 13, 2020
QUALITY ASSURANCE MANAGER in Baltimore, MD
Having studied your organization in detail, you not only have an outstanding reputation within the industry, but you are clearly serious about setting and maintaining high Quality Assurance standards.
February 02, 2020