Director of Total Quality Deployment jobs in South Portland, ME

Director of Total Quality Deployment deploys total quality operational excellence policies and programs within an organization. Develops master plans, timelines, and budget allocation for implementation. Being a Director of Total Quality Deployment forms and guides cross functional teams. Ensures programs educate and motivate employees to achieve a culture of continuous improvement. Additionally, Director of Total Quality Deployment utilizes Six Sigma/Lean methodologies and typically is certified as a Six Sigma Black Belt. Requires a bachelor's degree in engineering, manufacturing or similar area. Typically reports to senior management. The Director of Total Quality Deployment manages a departmental sub-function within a broader departmental function. Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure. To be a Director of Total Quality Deployment typically requires 5+ years of managerial experience. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function. (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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Software Deployment and Hardware Technician
  • MKS2 Technologies
  • Augusta, ME FULL_TIME
  • Software Deployment and Hardware Technician As an onsite Software Deployment and Hardware Technician on this project, you will be supporting the Department of Veterans' Affairs. You will analyze probl...
  • 6 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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Therapy - Clinic
  • Quality Clinicians
  • Berlin, NH FULL_TIME
  • Title: Physical Therapist Location: Berlin, New Hampshire Salary Range: $66,331.20 - $99,332.80 per year (Depending upon years of experience, to be negotiated at interview/offer) Work Schedule: Full-t...
  • 1 Day Ago

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RN Med Surg Ortho Lewiston, ME
  • Quality Clinicians
  • Lewiston, ME FULL_TIME
  • We are travelers building the kind of agency we always wanted, while we still work assignments. Pay Package: Weekly Pay Range: $1314-$2314/week Multiple shift openings Job Description/Responsibilities...
  • 3 Days Ago

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RN Orthopedics Lewiston, ME
  • Quality Clinicians
  • Lewiston, ME FULL_TIME
  • We are travelers building the kind of agency we always wanted, while we still work assignments. Pay Package: Weekly Pay Range: $1314-$2314/week Multiple shift openings Job Description/Responsibilities...
  • 10 Days Ago

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0 Director of Total Quality Deployment jobs found in South Portland, ME area

South Portland is a city in Cumberland County, Maine, United States, and is the fourth-largest city in the state, incorporated in 1898. As of the 2010 census, the city population was 25,002. Known for its working waterfront, South Portland is situated on Portland Harbor and overlooks the skyline of Portland and the islands of Casco Bay. Due to South Portland's close proximity to air, marine, rail, and highway transportation options, the city has become a center for retail and industry in the region. Despite the name, South Portland was never part of the city of Portland, but rather part of Cap...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Director of Total Quality Deployment jobs
$210,432 to $290,396
South Portland, Maine area prices
were up 1.6% from a year ago