Quality Assurance Specialist

1 week ago


Westbrook, Maine, United States KYYBA Full time
Job Overview

Position: Quality Assurance Specialist

Compensation: $24-$26/hr

Contract Type: W2 Contract (potential for extension)

Location: Onsite

Role Summary:

The Quality Assurance Specialist will engage in a variety of tasks to uphold the Quality Management System.

Key Responsibilities:

  • Execute product evaluations, including assessments for complaint investigations and stability checks.
  • Compile and present product testing outcome reports.
  • Examine production batch records for precision and thoroughness to authorize intermediate products for production use. Assess finished goods batch records, reporting any discrepancies and ensuring resolution before granting approval.
  • Conduct random inspections and audits of production processes.
  • Participate in the internal auditing framework.
  • Draft, review, and endorse Standard Operating Procedures (SOPs) as needed.
  • Support the Document Control program, including record retention and sample preservation.
  • Assist with the processing of returned instruments, including:
    • Logging returned instruments.
    • Decontaminating returned instruments in a controlled environment following established procedures.
    • Inspecting returned instruments for damage and documenting findings prior to further processing.
    • Managing instrument documentation for repair and packaging as necessary.

Qualifications:

  • Familiarity with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
  • Bachelor's degree in a scientific or technical field or equivalent experience. A minimum of one year in a quality assurance role within the medical device sector is preferred.
  • Ability to interpret safety regulations, operational instructions, and procedural manuals. Proficient in writing standard reports and communicating effectively in small group settings.
  • Competence in applying mathematical concepts such as fractions, percentages, and ratios to real-world scenarios.
  • Proficient in using database, internet, inventory, spreadsheet, and word processing software.
  • Strong adherence to procedures and meticulous documentation of results.
  • Understanding of manufacturing processes and the ability to identify deviations from established procedures.
  • Exceptional attention to detail.
  • Capability to utilize cleaning agents as required.


While performing the responsibilities of this position, the employee is regularly required to sit and stand, with occasional walking involved.

Work Environment: The characteristics of the work environment are typical of those encountered while fulfilling the essential functions of this role. Reasonable accommodations may be provided to enable individuals with disabilities to perform essential functions. The noise level in the work environment is generally quiet.



  • Westbrook, Maine, United States Collabera Full time

    Home Search Jobs Job Description Quality Assurance Specialist Contract Type: Temporary Compensation: $40.00 Per Hour Main Responsibilities:Conduct line clearance and shift transition tasks, ensuring proper setup and label verification. Actively engage in Quality Management System processes, including training, corrective and preventive actions (CAPA),...


  • Westbrook, Maine, United States KYYBA Full time

    Job OverviewThe role of **Quality Assurance Specialist** is integral to our operations within the Infectious Disease Developed Markets division. This position is essential for upholding the quality standards of our products, ensuring compliance with the regulations set forth by various governing bodies.Key Responsibilities:Conduct testing on in-process...


  • Westbrook, Maine, United States JobRialto Full time

    Position Overview We are seeking a Software Quality Assurance Specialist to enhance our testing capabilities for various applications, both in on-premises and cloud settings. Role Responsibilities This position will primarily focus on automated testing, accounting for over 75% of the workload, while also incorporating some manual testing tasks. Key...


  • Westbrook, Maine, United States JobRialto Full time

    Position Overview We are seeking a Software Quality Assurance Specialist to enhance our testing capabilities. This role is crucial for ensuring the quality of our applications across both on-premises and cloud platforms. Key Responsibilities Conduct primarily automated testing, focusing on over 75% automation. Utilize Java and SQL for testing and...


  • Westbrook, Maine, United States JobRialto Full time

    Position OverviewWe are seeking a talented Software Quality Assurance Specialist to enhance our testing capabilities. This role is essential for ensuring the reliability and performance of our applications across both on-premises and cloud platforms.Key ResponsibilitiesConduct automated testing, focusing on more than 75% of the testing process.Utilize Java...


  • Westbrook, Maine, United States ICONMA Full time

    Job SummaryWe are seeking a highly skilled Manufacturing Line Quality Assurance Specialist to join our team at ICONMA. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality in our manufacturing processes.Key ResponsibilitiesQuality System Implementation and Maintenance: Assist in the development and...


  • Westbrook, Maine, United States Complete Staffing Full time

    Job SummaryThe Quality Assurance Manager is responsible for overseeing all quality and food safety programs and functions to maintain standards for the manufacturing operations of Complete Staffing. This role involves managing a team of quality assurance professionals and ensuring compliance with regulatory requirements, customer standards, and internal...


  • Westbrook, Maine, United States Select Source International Full time

    Job OverviewPosition: Quality Assurance InspectorCompany: Select Source InternationalResponsibilitiesThe Quality Assurance Inspector will be responsible for:Conducting thorough evaluations of incoming materials to ensure compliance with quality standards.Overseeing the management of materials that do not meet specified performance criteria.Ensuring the...


  • Westbrook, Maine, United States Compunnel Inc. Full time

    Join Our Team as a Software Quality Assurance EngineerAre you an experienced QA Engineer seeking a new challenge? Compunnel Inc. is on the lookout for a dedicated Software Quality Assurance Engineer to enhance our testing efforts for existing applications across various environments, including both on-premises and cloud solutions. This position will...


  • Westbrook, Maine, United States kyyba Full time

    Position Overview:As a Quality Assurance Engineer in the manufacturing sector, you will play a crucial role in ensuring product integrity and compliance with quality standards.Contract Duration: 03+ Months Contract with potential for extension.Key Responsibilities:Conduct line clearance and shift change activities.Verify setups and labels to maintain quality...


  • Westbrook, Maine, United States Manpower Group Inc. Full time

    Position: Quality Assurance Engineer in Westbrook, MaineCompensation: $42 - $49.15 per hour, paid weeklyWork Schedule: 1st & 2nd shiftsContract Duration: TemporaryAre you a qualified professional with a bachelor's degree and at least two years of experience in quality assurance? If you are interested in a temporary position that offers competitive pay within...


  • Westbrook, Maine, United States ICONMA Full time

    Role Overview: The Quality Assurance Engineer for Manufacturing Operations serves as a vital Quality resource collaborating closely with Production teams to ensure adherence to Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Client quality standards. Key Responsibilities: Assist in the establishment and upkeep of a robust Quality...


  • Westbrook, Maine, United States Intellectt Inc Full time

    Position: Quality Assurance Engineer ILocation: Westbrook, MaineContract Duration: 5 Months on W2 Overview of Responsibilities: Collaborate with teams in Manufacturing, Information Management, Research and Development, Quality Assurance Operations, and Product Performance Analysis to ensure adherence to software development protocols and industry...


  • Westbrook, Maine, United States kyyba Full time

    Position Title: Quality Assurance and Manufacturing EngineerLocation: Westbrook, ME 04092Contract Duration: 03+ Months Contract with potential for extensionKey Responsibilities:Oversee line clearance, shift transition tasks, setup verification, and label validation.Actively engage in Quality System processes, which may encompass training, corrective action,...


  • Westbrook, Maine, United States KYYBA Full time

    Job OverviewPosition: Quality Control TechnicianLocation: Westbrook, MEContract Duration: 12+ months with potential for extensionKey Responsibilities:Conduct laboratory assessments and evaluations.Perform testing and execute calculations accurately.Occasional travel between various sites may be required.Prepare reports and maintain supporting...


  • Westbrook, Maine, United States LanceSoft, Inc. Full time

    Position: Manufacturing Line Quality EngineerOverview:The Manufacturing Line Quality Engineer serves as a vital Quality resource collaborating with Production to ensure compliance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and overall quality standards.Key Responsibilities:Conduct line clearance, manage shift transitions,...


  • Westbrook, Maine, United States LanceSoft, Inc. Full time

    Position: Manufacturing Line Quality EngineerOverview:The Manufacturing Line Quality Engineer serves as a vital Quality resource collaborating with Production to ensure compliance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and quality standards.Key Responsibilities:Conduct line clearance, shift transition activities, setup...


  • Westbrook, Maine, United States Cynet Systems Full time

    Job DescriptionWe are seeking a Product Packaging Specialist for our client.Position Title: Product Packaging SpecialistLocation: Not specifiedEmployment Type: ContractRole Overview:The selected candidate will be responsible for ensuring the quality and integrity of products through effective packaging practices.Key Responsibilities:Conduct inspections,...


  • Westbrook, Maine, United States JobsRUs Full time

    Job DescriptionJobsRUs is seeking a highly skilled Production Specialist to join our team in a dynamic manufacturing environment. As a Production Specialist, you will play a critical role in ensuring the production of high-quality medical diagnostic products while maintaining a clean and safe work environment.Key Responsibilities:Perform a variety of...


  • Westbrook, Maine, United States JobsRUs Full time

    Job DescriptionJobsRUs is seeking a skilled Production Specialist to join our team in a dynamic manufacturing environment. As a Production Specialist, you will play a critical role in producing high-quality medical diagnostic products while maintaining a clean and safe work environment.Key Responsibilities:Perform a variety of manufacturing tasks, including...