Current jobs related to Quality Engineer - Buffalo Grove - NEMERA

  • Quality Assurance Engineer

    3 weeks ago

    Buffalo Grove, United States CVS Pharmacy Full time

    This QA position at CVS Health in our Caremark PSS business unit, you will be testing various applications under the Adjudication Group. The applications you will test will include Enterprise Drug File, Pharmacy Networks and Drug Utilization Review ( Quality Assurance, Quality Assurance Engineer, Assurance, Information Technology, Engineer, Retail, QA

  • Quality Engineer

    3 months ago

    Buffalo Grove, United States Plexus Full time

    WHO WE ARE We're a global team of over 20,000 engineering, manufacturing, supply chain and sustaining service experts who partner with customers to bring their products to life through inspired innovation and world-class customer service. From surgical devices and health monitors to warehouse robotics and space products, we partner with our customers to help...

  • Quality Engineer

    3 months ago

    Buffalo Grove, United States Plexus Full time

    WHO WE ARE We’re a global team of over 20,000 engineering, manufacturing, supply chain and sustaining service experts who partner with customers to bring their products to life through inspired innovation and world-class customer service. From surgical devices and health monitors to warehouse robotics and space products, we partner with our customers to...

  • Quality Engineer

    3 months ago

    Buffalo Grove, United States Plexus Full time

    WHO WE ARE We're a global team of over 20,000 engineering, manufacturing, supply chain and sustaining service experts who partner with customers to bring their products to life through inspired innovation and world-class customer service. From surgical devices and health monitors to warehouse robotics and space products, we partner with our customers to...

  • Sr. Quality Engineer

    2 months ago

    Buffalo Grove, United States Aegis Worldwide Full time

    Job DescriptionJob DescriptionAegis is seeking a Sr. Quality Engineer for a client of ours in Lake Zurich, IL. Please see qualifications below and apply if you meet them. Bachelor’s degree in mechanical or industrial engineer, or industrial technology5-8+ years of quality experienceMUST have experience working in an ISO certified facility – specifically...

  • Quality Validation Engineer

    4 weeks ago

    Buffalo Grove, United States Nemera France SAS Full time

    Nemera is a world leader in the design, development, and manufacturing of drug delivery devices for the pharmaceutical, biotechnology, & generics industries. With locations worldwide, some of our services and products include eyedroppers, pumps, valves, inhalation devices, airless dispensers, and auto-injectors. Job Description The Quality Validation...

  • Quality Validation Engineer

    4 weeks ago

    Buffalo Grove, United States Nemera Full time

    Nemera is a world leader in the design, development, and manufacturing of drug delivery devices for the pharmaceutical, biotechnology, & generics industries. With locations worldwide, some of our services and products include eyedroppers, pumps, valves, inhalation devices, airless dispensers, and auto-injectors. Job Description The Quality Validation...

  • Senior Quality Assurance Engineer

    3 weeks ago

    Buffalo Grove, Illinois, United States Aegis Worldwide Full time

    Job OverviewAegis Worldwide is in search of a Senior Quality Assurance Engineer to join our team. This role is essential for ensuring the highest standards of quality in our processes and products.Key ResponsibilitiesPossess a Bachelor's degree in mechanical or industrial engineering, or industrial technology.Bring 5-8+ years of relevant quality assurance...

  • Quality Validation Engineer

    4 weeks ago

    Buffalo Grove, United States Nemera Full time

    Nemera is a world leader in the design, development, and manufacturing of drug delivery devices for the pharmaceutical, biotechnology, & generics industries. With locations worldwide, some of our services and products include eyedroppers, pumps, valves, inhalation devices, airless dispensers, and auto-injectors. Job Description The Quality Validation...

  • Quality Validation Engineer

    1 month ago

    Buffalo Grove, United States NEMERA Full time

    Nemera is a world leader in the design, development, and manufacturing of drug delivery devices for the pharmaceutical, biotechnology, & generics industries. With locations worldwide, some of our services and products include eyedroppers, pumps, valves, inhalation devices, airless dispensers, and auto-injectors.Job DescriptionThe Quality Validation Engineer...

  • Quality Validation Engineer

    1 month ago

    Buffalo Grove, United States NEMERA Full time

    Nemera is a world leader in the design, development, and manufacturing of drug delivery devices for the pharmaceutical, biotechnology, & generics industries. With locations worldwide, some of our services and products include eyedroppers, pumps, valves, inhalation devices, airless dispensers, and auto-injectors.Job DescriptionThe Quality Validation Engineer...

  • Quality Validation Engineer

    3 weeks ago

    Buffalo Grove, United States Nemera Full time

    Company Description Nemera is a world leader in the design, development, and manufacturing of drug delivery devices for the pharmaceutical, biotechnology, & generics industries. With locations worldwide, some of our services and products include eyedroppers, pumps, valves, inhalation devices, airless dispensers, and auto-injectors. Job Description The...

  • Senior Quality Assurance Engineer

    3 weeks ago

    Buffalo Grove, Illinois, United States Aegis Worldwide Full time

    Position OverviewAegis Worldwide is in search of a Senior Quality Assurance Engineer to join our dynamic team. This role is essential for ensuring the highest standards of quality in our processes and products.Key ResponsibilitiesPossess a Bachelor's degree in mechanical or industrial engineering, or industrial technology.Bring 5-8+ years of extensive...

  • Senior Quality Assurance Engineer

    3 weeks ago

    Buffalo Grove, Illinois, United States Aegis Worldwide Full time

    Job OverviewAegis Worldwide is looking for a Senior Quality Assurance Engineer to support our client. Below are the qualifications we seek:Educational Background: A degree in mechanical or industrial engineering, or industrial technology is required.Experience: A minimum of 5-8 years in quality assurance roles is essential.ISO Certification Experience:...

  • Intern - Quality Engineer - Summer 2025

    4 weeks ago

    Buffalo Grove, United States Plexus Full time

    Our people create our best Plexus. WHAT WE DO AT PLEXUS We're a global team of over 20,000 engineering, manufacturing, supply chain and aftermarket service experts who partner with customers to bring their products to life through inspired innovation and world-class customer service. We are passionate about innovating, creating and delivering products...

  • Quality Engineer

    3 weeks ago

    Buffalo, United States Motion Recruitment Full time

    Our Client is seeking a Quality Engineer (QE) for a full time opportunity at their Buffalo, NY operation.While the ideal candidate comes from a nuclear background, our client is open to any quality engineering experience in another highly regulated industry such as Medical, FDA, etc. This role requires 15% travel for audits.Top Experience Required:Bachelors'...

  • Quality Engineer

    2 weeks ago

    Buffalo, United States Motion Recruitment Full time

    Our Client is seeking a Quality Engineer (QE) for a full time opportunity at their Buffalo, NY operation.While the ideal candidate comes from a nuclear background, our client is open to any quality engineering experience in another highly regulated industry such as Medical, FDA, etc. This role requires 15% travel for audits.Top Experience Required:Bachelors'...

  • Manufacturing and Quality Engineer

    3 weeks ago

    Buffalo, New York, United States Altec Industries Full time

    Your OrganizationAltec Industries is seeking a dedicated individual for a versatile engineering position at our facility. This role reports directly to the Engineering Manager and is part of a dynamic team where engineering functions are not strictly divided.Role OverviewAs a Manufacturing and Quality Engineer, you will play a crucial role in enhancing our...

  • Quality Engineer

    4 months ago

    Buffalo, United States Mirion Technologies (Conax Nuclear), Inc Full time

    Job DescriptionJob DescriptionThe Quality Engineer (QE) is responsible for the implementing and management of a comprehensive nuclear quality assurance program compliant with: 10CFR50 Appendix B; 10CFR21; ASME Code and ASME NQA-1; and ANSI as necessary. This includes, but is not limited to, the management of a quality assurance program; review/acceptance of...

  • Quality Assurance Specialist

    3 days ago

    Buffalo Grove, Illinois, United States Plexus Full time

    About the RoleWe're seeking a highly skilled Quality Engineer to join our team at Plexus Corp. As a Quality Engineer, you will play a critical role in ensuring the quality and compliance of our products.Key ResponsibilitiesLead the determination of non-conformance and customer complaints through containment, root cause, corrective action, and audits.Ensure...

Quality Engineer

4 months ago

Buffalo Grove, United States NEMERA Full time

Nemera is a world leader in the design, development, and manufacturing of drug delivery devices for the pharmaceutical, biotechnology, & generics industries. With locations worldwide, some of our services and products include eyedroppers, pumps, valves, inhalation devices, airless dispensers, and auto-injectors.

Job Description

The Quality Validation Engineer is responsible for planning, coordinating and managing through completion, assigned projects to ensure the development and production of products meets customer and internal quality deliverables. Coordinate and lead investigations regarding customer complaints. Work with Supply Chain management to evaluate and manage supplier performance. Duties and responsibilities are accomplished personally or through collaboration with other staff.

Description for Internal Candidates

Responsibilities:

  • Assists the Quality Manager in coordinating and executing objectives throughout the company in cooperation with other departments, to maximize product quality and operating system efficiency/effectiveness while minimizing cost
  • Identify and coordinate resolution of system inefficiencies that contribute to increased quality costs.
  • Coordinate and manage the execution of validations and creation of written protocols.
  • Coordinate and manage the execution of change control activities.
  • Assess results of Customer Complaint investigations and Corrective Actions for application, validity and conformance to FDA regulatory, QSR, ISO and Customer requirements.
  • Utilize CAPA problem solving techniques to reduce internal and external failures, selects sound techniques (FMEA, Design of Experiments, Cause and Effect, Flow Charts, SPC) to solve problems effectively, and assess results for application, validity and conformance to specifications.
  • Develop and analyze statistical data in relationship to assigned tasks to determine adequacy of present standards and establish proposed quality improvements, including analysis of current inspection methods and sample plans.
  • Evaluate compliance using relevant information and individual judgment to determine whether events or processes comply with specifications, operating procedures or standards.
  • Develop product specifications for existing products and assess existing specifications for accuracy and compliance.
  • Plan, coordinate, and manage assigned Supplier Quality evaluations through scheduling and auditing of suppliers.
  • Interact with suppliers and ensures mutual interpretation of specified requirements to make certain customer requirements and objectives are met.
  • Support implementation and management of quality agreements with assigned suppliers.
  • Plan, promote, perform and organize training activities for internal departments related to quality activities, including basic statistics, DOE, GR&R and Sample Plan designation.
  • Interact with customers to assure mutual interpretation of specified requirements to ensure fulfilment of customer requirements and objectives are met.
  • Assist the Quality Managers during customer audits and lead to final resolution any findings/observations resulting from the audits.
  • Assist in maintaining ISO and FDA QSR quality systems compliance.
  • Execute specific responsibilities as defined within the company quality operating system.
  • Support and maintain all policies of the company, including but not limited to applicable FDA regulatory and ISO requirements, Health and Safety Requirements and Continuous Improvement initiatives.
  • Identify and complete continuous improvement projects utilizing Six Sigma tools and methodologies.
  • Other duties as assigned.

Preferred/Required Education/Skills:

  • Bachelor’s degree in Engineering, Science or related field.
  • 3+years' of experience in a Quality position strongly preferred.
  • Experience in the Medical Device industry strongly preferred (ISO13485)
  • Experience with technical writing, IQ/OQ/PQ is preferred
  • Experience with equipment validation is preferred
  • Experience working onsite in Manufacturing is strongly preferred
  • Excellent communication skills with the ability to understand, read, write and speak English required.
  • Must have the ability to apply advanced mathematical concepts and intermediate statistical (SPC) knowledge.
  • Six-sigma experience, training or certification preferred.
  • Intermediate level computer skills, including Microsoft Office applications required.
  • SAP experience preferred.
  • Ability to work independently from verbal and/or written instructions required.
  • Ability to understand and articulate how individual role and responsibilities tie into Quality department function, goals and objectives

Work Environment

  • Works in a clean manufacturing environment that may include moderate noise levels and required appropriate PPE and cleanroom apparel.
  • Ability to regularly lift up to 30 lbs with repetitive movements.
  • Ability to push and pull items.
  • Ability to stand, sit, walk up to 80% of a shift.
  • Ability to travel between office and production departments as well as company buildings required.
  • Up to 25% travel required (some international).

Qualifications

  • Bachelor’s degree in Engineering, Science or related field.
  • 3+years' of experience in a Quality position strongly preferred.
  • Experience in the Medical Device industry strongly preferred (ISO13485)
  • Experience with technical writing, IQ/OQ/PQ is preferred
  • Experience with equipment validation is preferred
  • Experience working onsite in Manufacturing is strongly preferred
  • Excellent communication skills with the ability to understand, read, write and speak English required.
  • Must have the ability to apply advanced mathematical concepts and intermediate statistical (SPC) knowledge.
  • Six-sigma experience, training or certification preferred.
  • Intermediate level computer skills, including Microsoft Office applications required.
  • SAP experience preferred.
  • Ability to work independently from verbal and/or written instructions required.
  • Ability to understand and articulate how individual role and responsibilities tie into Quality department function, goals and objectives

Additional Information

All your information will be kept confidential according to EEO guidelines.

Nemera is a world leader in the design, development, and manufacturing of drug delivery devices for the pharmaceutical, biotechnology, & generics industries. With locations worldwide, some of our services and products include eyedroppers, pumps, valves, inhalation devices, airless dispensers, and auto-injectors.

We put patients first when creating drug delivery devices because we know that accurate dosing and ergonomics contribute to patients completing their treatment. Working at Nemera means being part of a team that truly enjoys working together and always goes the extra mile to deliver on its commitments. We’re proud of the work we do because it improves patients’ lives.

Nemera is an equal opportunity employer and does not discriminate against any person on the basis of race, religion, color, gender, gender identity, sexual orientation, age, national origin, disability, veteran status, or any other protected class indication. This company is required by federal law to hire only persons who can establish they are eligible to work in the United States.

The Nemera timekeeping system utilizes finger scan. Our biometric policy is available upon request at bghr@nemera.net