Senior Quality Assurance Engineer

2 weeks ago


Middletown, Virginia, United States Thermo Fisher Scientific Full time
Work Schedule

Standard (Mon-Fri)

Environmental Conditions


Compliance with all Good Manufacturing Practices (GMP) Safety Standards, Office environment, with some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.).

Exposure to hazardous/toxic materials is expected.

Job Overview


Are you a seasoned Engineer eager to leverage your expertise in a pivotal role? Thermo Fisher Scientific Inc. is on the lookout for a Senior Quality Assurance Engineer who has demonstrated a history of impactful contributions to join our esteemed team.


This position is based in Middletown and offers a unique opportunity to make a significant difference.


Key Responsibilities:
  • Establish and execute quality assurance protocols, processes, and standards.
  • Collaborate with diverse teams to ensure impeccable execution of quality control measures.
  • Perform thorough testing and analysis to pinpoint areas for enhancement and optimization.
  • Oversee and collaborate with team members to ensure daily operational adherence to the quality management system (QMS) and other regulatory, ISO, and international standards.
  • Enhance product and process quality through direct support and oversight of production value streams and new developments.
  • Lead and assist in the investigation of nonconformance, audit findings, CAPA's, complaints, environmental alerts, and SCAR's by conducting CAPA investigations, risk assessments (FMEA, DFMEA, PFMEA), root cause analysis, and effectiveness checks.
  • Support the preparation and approval of change control documents related to the enhancement of operational processes.
  • Thrive in a fast-paced environment to meet stringent deadlines.
  • Conduct internal and participate in external Quality System audits to evaluate compliance with the QMS, FDA regulations, ISO standards, EU IVDR, and other international regulations.
  • Successfully implement continuous improvement initiatives to boost overall quality and efficiency.

Qualifications:
  • Bachelor's degree in Engineering or a related discipline, or equivalent experience.
  • Demonstrated experience in quality assurance within an engineering context.
  • Comprehensive understanding of quality control methodologies and effective strategies.
  • Outstanding problem-solving and analytical capabilities.
  • Familiarity with global regulatory and quality requirements associated with medical devices, including ISO 13485, ISO 14971, and 21 CFR Part 820.
  • Knowledge of IVDR and MDR is advantageous.
  • Experience in liquid formulation and filling operations is a plus.
  • ASQ certified quality engineer, ASQ certified quality auditor, and/or Six Sigma/Lean certified is a plus.
  • Exceptional communication and teamwork skills.

At Thermo Fisher Scientific, we celebrate diverse experiences, backgrounds, and perspectives. We are an equal opportunity employer, dedicated to providing reasonable accommodations for individuals with disabilities during the application process. We look forward to supporting you in your career journey.

  • Middletown, Virginia, United States Thermo Fisher Scientific Full time

    Work Schedule:Second Shift (Afternoons)Environmental Conditions:Compliance with all Good Manufacturing Practices (GMP) Safety Standards is essential. Some degree of Personal Protective Equipment (PPE) is required, including safety glasses, gowning, gloves, lab coat, and ear plugs.Job Overview:Position Summary:The individual in this role will be trained to...


  • Middletown, Virginia, United States Thermo Fisher Scientific Full time

    Job DescriptionAs a key member of the Thermo Fisher Scientific team, you will play a critical role in supporting the validation of our products and processes. This includes automation equipment, product transfers, new product development, and working as part of a cross-functional team responsible for sustaining change.Key ResponsibilitiesAssist the...


  • Middletown, Virginia, United States Thermo Fisher Scientific Full time

    Job DescriptionAs a key member of the Thermo Fisher Scientific team, you will play a critical role in supporting the validation of our products and processes. This includes automation equipment, product transfers, new product development, and working as part of a cross-functional team responsible for sustaining change.Key ResponsibilitiesAssist the...


  • Middletown, Virginia, United States Maxonic Full time

    Maxonic values its enduring partnerships with clients. To meet their requirements, we are seeking a Quality Control Specialist II. Position Overview: As a member of the team, our organization supports some of the leading manufacturers of in vitro diagnostic (IVD) products, serving as their original equipment manufacturer (OEM) and contract production...

  • Engineer II

    2 weeks ago


    Middletown, Virginia, United States Thermo Fisher Scientific Full time

    Work Schedule Standard (Mon-Fri) Environmental Conditions Ability to lift 40 lbs. without assistance, adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom regulations: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair, etc. are permitted, exposure to loud noises from equipment/machinery,...


  • Middletown, Virginia, United States Thermo Fisher Scientific Full time

    Work Schedule Standard (Mon-Fri) Environmental Conditions Ability to lift 40 lbs. without assistance, adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. allowed, exposure to loud noises (Equipment/Machinery), no contact lenses permitted;...


  • Middletown, Virginia, United States Thermo Fisher Scientific Full time

    Work ScheduleStandard (Monday to Friday)Environmental ConditionsAbility to lift up to 40 lbs. independently, compliance with all Good Manufacturing Practices (GMP)Safety Standards and Cleanroom Requirements:No hair products, jewelry, makeup, nail polish, perfume, exposed piercings, or facial hair permitted. Exposure to loud noises from equipment and...


  • Middletown, United States AllSearch Professional Staffing Full time

    Join Our Team as a Quality Assurance EngineerAllSearch Professional Staffing is seeking a dedicated Quality Assurance Engineer to enhance our manufacturing operations. This role is essential in maintaining our commitment to quality and excellence across various sectors.Key Responsibilities:Revise and enhance Quality Management System documentation to comply...


  • Middletown, Pennsylvania, United States Advanced Conversion Technology, Inc. Full time

    About Us - Our ValuesAt Advanced Conversion Technology, Inc., we are committed to:A dedicated team that supports the United States military by addressing challenges and delivering innovative solutions that safeguard our personnel;A focused group on the development of cutting-edge technology utilized in advanced military defense systems;A stable, expanding,...


  • Middletown, Delaware, United States Clarios Full time

    Role Overview Under the guidance of the Quality Manager and in alignment with company policies, the Quality Assurance Engineer is responsible for designing, developing, and executing continuous improvement and process control strategies to meet quality standards for products and manufacturing operations. This role involves conducting investigations into...


  • Middletown, United States Bestlogic Staffing Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at BestLogic Staffing. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and services.Key ResponsibilitiesDevelop and Implement Quality StrategiesDevelop and implement strategies to achieve quality department goals,...


  • Middletown, United States On Line Design, Inc. Full time

    Quality Assurance TechnicianOn Line Design is actively looking for dedicated Quality Assurance Technicians to join our team. This position plays a crucial role in maintaining the integrity of production lines by ensuring they adhere to established quality benchmarks through meticulous inspection processes, testing protocols, and necessary...


  • Middletown, Pennsylvania, United States Info Matrix Corp Full time

    About the RoleInfo-Matrix Corporation is seeking a highly skilled Senior Quality Assurance Automation Lead to join our team. As a key member of our quality assurance team, you will be responsible for leading the development and implementation of automated testing strategies for our SAP and MS Dynamics environments.Key ResponsibilitiesDevelop and maintain...


  • Middletown, United States SAIC Full time

    About the RoleSAIC is seeking a highly skilled Quality Assurance Specialist to support manufacturing and engineering activities, including design, test, modification, fabrication, and assembly of electromechanical systems and specialized test equipment.Key ResponsibilitiesDevelop and execute inspection plans to verify conformance with specifications and...

  • Quality Engineer

    1 week ago


    Middletown, United States Surf Search Full time

    Our client is looking for a talented and dedicated Quality Engineer to join our exceptional team. If you possess excellent problem-solving skills and a strong commitment to quality, we want to hear from you!Essential Duties and Responsibilities:Develop and implement strategies to achieve Quality department goals, aligning with project schedules and contract...

  • Quality Engineer

    2 days ago


    Middletown, United States Bestlogic Staffing Full time

    Our client is looking for a talented and dedicated Quality Engineer to join our exceptional team. If you possess excellent problemsolving skills and a strong commitment to quality we want to hear from you! Essential Duties and Responsibilities: Develop and implement strategies to achieve Quality department goals aligning with project schedules and contract...


  • Middletown, Rhode Island, United States SAIC Full time

    SAIC is currently in search of a Quality Assurance Specialist to evaluate our electrical mechanical testing systems, ensuring adherence to product standards. In this capacity, you will perform systematic quality evaluations throughout the manufacturing process, which includes receiving, in-process, and final assessments. During these evaluations, you will...


  • Middletown, United States AllSearch Professional Staffing Full time

    Join Our Team as a Quality Assurance EngineerAllSearch Professional Staffing is seeking a dedicated Quality Assurance Engineer to enhance our manufacturing operations. This role is pivotal in ensuring that our products meet the highest standards of quality and reliability.Key Responsibilities:Revise and refine Quality Management System protocols to comply...


  • Middletown, Rhode Island, United States Chili's Grill & Bar Full time

    Job SummaryWe are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team at Chili's Grill & Bar. As a Quality Assurance Specialist, you will play a critical role in ensuring that every guest receives perfectly prepared, high-quality food and exceptional service.Key ResponsibilitiesFood Preparation and Quality Control:...

  • Quality Manager

    3 weeks ago


    Middletown, United States ContractStaffingRecruiters.com Full time

    The Quality Manager will oversee and manage all aspects of quality assurance and control within our aerospace manufacturing operations. This role is crucial in ensuring that our products comply with industry standards, regulatory requirements, and customer specifications. The Quality Manager will lead a team of quality professionals, implement robust quality...

  • Quality Manager

    3 weeks ago


    Middletown, United States ContractStaffingRecruiters.com Full time

    The Quality Manager will oversee and manage all aspects of quality assurance and control within our aerospace manufacturing operations. This role is crucial in ensuring that our products comply with industry standards, regulatory requirements, and customer specifications. The Quality Manager will lead a team of quality professionals, implement robust quality...


  • Middletown, Pennsylvania, United States Advanced Conversion Technology, Inc. Full time

    About the RoleAdvanced Conversion Technology, Inc. is seeking a skilled Quality Engineer to join our team. As a Quality Engineer, you will play a critical role in ensuring our products meet the highest quality standards.Key ResponsibilitiesDevelop and implement continuous process improvement systems company-wideCollaborate with cross-functional teams to...


  • Middletown, United States Advanced Conversion Technology, Inc. Full time

    About the RoleAdvanced Conversion Technology, Inc. is seeking a skilled Quality Engineer to join our team. As a Quality Engineer, you will play a critical role in ensuring our products meet the highest quality standards.Key ResponsibilitiesDevelop and implement continuous process improvement systems company-wideEnsure products are developed, manufactured,...


  • Middletown, Rhode Island, United States MIKEL INC Full time

    Become a Key Player as an Engineering Quality Control TechnicianMIKEL INC is a dedicated woman-owned enterprise focused on providing advanced Undersea Warfare Solutions for the U.S. Navy. Since our inception in 1999, we have been committed to delivering innovative and cost-efficient solutions that consistently surpass client expectations.We are on the...

  • Quality Engineer

    3 months ago


    Middletown, United States Advanced Conversion Technology, Inc. Full time

    Who We Are - Our CultureWhen you join Advanced Conversion Technology (ACT), you join:A team who proudly supports the United States military through solving problems and providing innovative solutions that protect our troops;A team laser focused on developing unique next-generation technology found on state-of-the-art military defense platforms;A growing,...


  • Middletown, Pennsylvania, United States Compunnel Inc. Full time

    Quality Assurance Validation Specialist (Contract)Compensation: $90 per hourContract Duration: 3 monthsWork Schedule: Monday to Friday (Flexible hours - Full-Time)Note: Candidates must be local and willing to commute to the office.Key Responsibilities:Design and implement XML structures that encapsulate product-specific data to facilitate autonomous testing...


  • Middletown, United States SAIC Full time

    Job SummarySAIC is seeking a highly skilled Quality Engineer to support manufacturing and engineering activities, including design, test, modification, fabrication, and assembly of electromechanical systems and specialized test equipment.Key ResponsibilitiesDevelop and execute inspection and testing plans to verify product conformance with specifications and...