Quality Engineer I or II

1 week ago

Morristown, United States Rockline Industries & Iatric Manufacturing Full time
ESSENTIAL ACCOUNTABILITIES:

  • Facilitate and maintain validation project documentation, including site's Validation Master Plan.
    • Write Protocol.
    • Execute Installation, Operation and Performance Qualification.
    • Write final report for each qualification.
    • Attend formal training on related software and/or equipment.
    • Work closely with customer in development of validation requirements and protocols. Maintain validation protocol
  • Serve as the Database administrator for Infinity QS (Statistical Process Control) software.
    • Developing project databases to support Quality inline checks and manufacturing.
    • Add associates to the database and assign login and passwords.
    • Add process(s) and part(s) as necessary to support manufacturing.
    • Update specifications to critical quality measures supporting our customer requirements.
    • Troubleshoot application errors, assign root cause, determine solution and implement solution.
    • Maintain input testing equipment for critical quality measurements.
    • Provide Training on Statistical Process Control
  • Provide statistical analysis support for manufacturing, new product development (NPD), trials, and validation activities.
  • Develop SOP's relating to validation and risk management.
  • Monitor and prepare Key Performance Indicators (KPI's) for major customers.
  • Conduct quality/engineering studies to support manufacturing operations.
  • Facilitate Corrective Action / Preventative Action (CAPA) activities to identify and resolve root cause issues through sound investigation and effective problem-solving techniques to solve problems within the manufacturing plant.
    • Facilitate KT sessions for CAPA Projects.
    • Execute the Effectiveness Check.
    • Provide Training on the CAPA process
  • Facilitate and train associates on quality topics required for their position (SPC / CAPA).
  • Coordinate continuous improvement initiatives alongside internal and external (customer or supplier) representatives.
QUALIFICATION REQUIREMENTS: (To perform this job successfully, an individual must be able to perform each of the essential accountabilities satisfactorily.The requirements listed below are representative of the knowledge, skill, and/or ability required.)

Quality Engineer I
  • Bachelor's degree in Engineering, science or related field is required.
  • Engineering experience, preferably in a manufacturing environment is desired.
  • Experience in an FDA-regulated environment preferred.
  • Strong self-starter with the ability to work independently as well as collaboratively in a team setting with peers and colleagues in a cross-functional setting.
  • Demonstrated ability to perform technical Non-Conformance Investigations and Root Cause Analyses.
  • Ability to prioritize and handle multiple tasks; ability to meet deadlines in a fast-paced work environment.
  • Ability to have a flexible work schedule to support department projects and coordinate with production and validation schedules.
  • Technical background in nutritional products, laboratory diagnostics, medical devices, pharmaceutical or similar industry.
Quality Engineer II
  • Bachelor's degree in Engineering, science or related field is required plus three or more years of engineering experience, preferably in a manufacturing environment.
  • Technical background in nutritional products, laboratory diagnostics, medical devices, pharmaceutical, or similar industry. Experience in an FDA-regulated environment preferred
  • Demonstrated ability to perform technical Non-Conformance investigations and Root Cause Analysis.
  • Ability to work independently as well as collaboratively in a team setting with peers and colleagues in a cross functional setting.
  • Able to prioritize and handle multiple tasks and ability to meet deadlines in a fast-paced work environment.
  • Ability to have a flexible work schedule to support department activities and coordinate with production and validation execution schedules.


PHYSICAL AND MENTAL REQUIREMENTS: (The physical demands described here are representatives of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions)
1. Must be able to communicate face-to-face and over the phone
2. Occasional lifting up to 35 lbs.
3. Frequent standing/walking. Occasional sitting, bending, twisting, kneeling, climbing, pushing/pulling and reaching.
4. Repetitive hand and foot movement.
5. Work environment includes occasional noise, hot and cold temperatures.
6. Requires ability to read, write, calculate and analyze.

FLSA: Exempt

Grade: 10 or 11

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

  • Chemist I or II

    1 week ago

    Morristown, Tennessee, United States Rockline Industries & Iatric Manufacturing Full time

    About the Job:We are looking for skilled Chemists to join our team and contribute to our laboratory operations. If you are passionate about microbiological testing, chemical testing, and physical testing, then this position might be a great fit for you!ESSENTIAL ACCOUNTABILITIES:Perform microbiological testing including sample preparation, testing following...

  • Chemist I or II

    1 month ago

    Morristown, United States Rockline Industries Full time

    ESSENTIAL ACCOUNTABILITIES: * Microbiological Testing * Regular duties as a Microbiologist including: * Sample preparation and testing following USP and * Aseptic technique * Gram staining and phenotypic ID using API * Environmental Monitoring in Plant * Maintain Micro Test Logs * CPM of Plant water loop * Chemical Testing * GC - Maintenance and...

  • Chemist I or II

    3 weeks ago

    Morristown, United States Rockline Industries Full time

    ESSENTIAL ACCOUNTABILITIES: * Microbiological Testing * Regular duties as a Microbiologist including: * Sample preparation and testing following USP and * Aseptic technique * Gram staining and phenotypic ID using API * Environmental Monitoring in Plant * Maintain Micro Test Logs * CPM of Plant water loop * Chemical Testing * GC - Maintenance and...

  • Chemist I or II

    1 month ago

    Morristown, United States Rockline Industries Full time

    ESSENTIAL ACCOUNTABILITIES: Microbiological Testing Regular duties as a Microbiologist including: Sample preparation and testing following USP and Aseptic technique Gram staining and phenotypic ID using API Environmental Monitoring in Plant Maintain Micro Test Logs CPM of Plant water loop Chemical Testing GC – Maintenance and OperationHPLC...

  • Quality Engineer

    4 weeks ago

    Morristown, United States Aegis Worldwide Full time

    Job Title: Quality Engineer - Heavy Industrial EnvironmentJob Overview: As a Quality Engineer in a heavy industrial environment, you will be responsible for ensuring that products meet quality standards and customer specifications throughout the manufacturing process. You will collaborate with various teams to develop and implement quality control...

  • Quality Engineer

    4 weeks ago

    Morristown, United States Thermon, Inc. Full time

    Vapor Power/Precision Boilers is in search of a Quality Engineer who will play a critical role in ensuring the production of high-quality products in compliance with ASME code for pressure vessels and ISO9001 quality system requirements. In this hands-on position, the primary responsibility is to execute all ASME essential duties and responsibilities, while...

  • Quality Engineer

    3 days ago

    Morristown, United States Thermon, Inc. Full time

    Vapor Power/Precision Boilers is in search of a Quality Engineer who will play a critical role in ensuring the production of high-quality products in compliance with ASME code for pressure vessels and ISO9001 quality system requirements. In this hands-on position, the primary responsibility is to execute all ASME essential duties and responsibilities, while...

  • Quality Engineer

    3 weeks ago

    Morristown, United States Thermon Full time

    Job DescriptionJob DescriptionVapor Power/Precision Boilers is in search of a Quality Engineer who will play a critical role in ensuring the production of high-quality products in compliance with ASME code for pressure vessels and ISO9001 quality system requirements. In this hands-on position, the primary responsibility is to execute all ASME essential...

  • Quality Engineer

    4 weeks ago

    Morristown, United States Thermon, Inc. Full time

    Vapor Power/Precision Boilers is in search of a Quality Engineer who will play a critical role in ensuring the production of high-quality products in compliance with ASME code for pressure vessels and ISO9001 quality system requirements. In this hands-on position, the primary responsibility is to execute all ASME essential duties and responsibilities, while...

  • Quality Engineer

    4 weeks ago

    Morristown, United States Thermon Full time

    Job DescriptionJob DescriptionVapor Power/Precision Boilers is in search of a Quality Engineer who will play a critical role in ensuring the production of high-quality products in compliance with ASME code for pressure vessels and ISO9001 quality system requirements. In this hands-on position, the primary responsibility is to execute all ASME essential...

  • Quality Engineer

    3 weeks ago

    Morristown, United States Thermon, Inc. Full time

    Vapor Power/Precision Boilers is in search of a Quality Engineer who will play a critical role in ensuring the production of high-quality products in compliance with ASME code for pressure vessels and ISO9001 quality system requirements. In this hands-on position, the primary responsibility is to execute all ASME essential duties and responsibilities, while...

  • Welding Quality Engineer

    4 weeks ago

    Morristown, United States Aegis Worldwide Full time

    Job DescriptionJob DescriptionJob Title: Quality Engineer - Heavy Industrial EnvironmentJob Overview: As a Quality Engineer in a heavy industrial environment, you will be responsible for ensuring that products meet quality standards and customer specifications throughout the manufacturing process. You will collaborate with various teams to develop and...

  • Welding Quality Engineer

    4 weeks ago

    Morristown, United States Aegis Worldwide Full time

    Job DescriptionJob DescriptionJob Title: Quality Engineer - Heavy Industrial EnvironmentJob Overview: As a Quality Engineer in a heavy industrial environment, you will be responsible for ensuring that products meet quality standards and customer specifications throughout the manufacturing process. You will collaborate with various teams to develop and...

  • Manufacturing Quality Engineer

    2 months ago

    Morristown, United States Aegis Worldwide Full time

    Job DescriptionJob DescriptionJob Title: Quality Engineer - Heavy Industrial EnvironmentJob Overview: As a Quality Engineer in a heavy industrial environment, you will be responsible for ensuring that products meet quality standards and customer specifications throughout the manufacturing process. You will collaborate with various teams to develop and...

  • Welding Quality Engineer

    3 weeks ago

    Morristown, United States Aegis Worldwide Full time

    Job DescriptionJob DescriptionJob Title: Quality Engineer - Heavy Industrial EnvironmentJob Overview: As a Quality Engineer in a heavy industrial environment, you will be responsible for ensuring that products meet quality standards and customer specifications throughout the manufacturing process. You will collaborate with various teams to develop and...

  • huc ii

    7 days ago

    Morristown, Tennessee, United States Covenant Health (Tennessee) Full time

    Overview: Unit Secretary, Surgical Unit Full Time, 72 Hours Per Pay Period, Night Shift Morristown-Hamblen Healthcare System has 167 licensed beds and 23 emergency suites. The hospital offers outstanding ancillary services including Laboratory, Radiology and Therapy services. At our Breast Imaging Center of Excellence, women can have their annual...

  • Quality Engineer

    4 weeks ago

    Morristown, United States KLM Careers Full time

    Quality Engineer - TN Morristown, TN Must be a US Citizen or Green Card holder. This position develops and executes validation protocols (IQ / OQ / PQ) as required for equipment, sanitization/cleaning, facilities, software, and processes. This job will also work with customers regarding customer-specific equipment and process validations. ESSENTIAL...

  • Quality Engineer

    2 months ago

    Morristown, United States KLM Careers Full time

    Job DescriptionJob DescriptionQuality Engineer - TNMorristown, TNMust be a US Citizen or Green Card holder.This position develops and executes validation protocols (IQ / OQ / PQ) as required for equipment, sanitization/cleaning, facilities, software, and processes. This job will also work with customers regarding customer-specific equipment and process...

  • Quality Engineer

    3 weeks ago

    Morristown, United States KLM Careers Full time

    Quality Engineer - TN Morristown, TN Must be a US Citizen or Green Card holder. This position develops and executes validation protocols (IQ / OQ / PQ) as required for equipment, sanitization/cleaning, facilities, software, and processes. This job will also work with customers regarding customer-specific equipment and process validations. ESSENTIAL...

  • Quality Engineer

    3 weeks ago

    Morristown, United States KLM Careers Full time

    Job DescriptionJob DescriptionQuality Engineer - TNMorristown, TNMust be a US Citizen or Green Card holder.This position develops and executes validation protocols (IQ / OQ / PQ) as required for equipment, sanitization/cleaning, facilities, software, and processes. This job will also work with customers regarding customer-specific equipment and process...