Jobs
>
Quality Engineer
>
Arlington Heights

    Quality Engineer - Arlington Heights, United States - Katalyst Healthcares and Life Sciences

    Katalyst Healthcares and Life Sciences
    Katalyst Healthcares and Life Sciences Arlington Heights, United States

    1 day ago

    Default job background
    Description
    Responsibilities:
    • Participate in global quality engineering activities in software product development, manufacturing, and support including engineering design review, verification/ validation activities.
    • ble to define design document requirements for process and test method validation within Design Control and Software Development Life Cycle {SDLC). Reviews and approves software lifecycle deliverables.
    • Directly influences project direction and scope, guides product development teams through design validation and regulatory compliance and assures robust product vs. customer requirements.
    • pplies established quality and engineering methods to the investigation and solution of software quality problems. Supports CAPA {Corrective Action Preventive Action) and FCA (Field Corrective Action) activities as required.
    • Participates, through the creation and review of improvements of software development, software processes, and documentation processes.
    • Supports supplier qualification and maintenance activities. Performs SCAR {Supplier Corrective Action), and process deviation activities.
    • Participate in internal and external (i.e., FDA, Registrar, Notified Bodies) audits.
    • Understands and assesses the impact of a change on the safety and efficacy of a software product, device, process performance, and internal/external customer expectations worldwide.
    • Participates in Risk Management activities. Assesses internal and external risks associated with specific actions, quantifies risks, seeks input from others, and identifies actions to limit the exposure of the division.
    • Supports and provides oversight to non-product software lifecycle activities including review and assessment of software activities {suppler evaluations, validation, lifecycle deliverable documents) to ensure compliance with applicable procedures, standards, and regulatory requirements.
    • Participates in multi-site and business wide software lifecycle activities to accomplish quality system objectives.
    • Investigates and analyses impact of failure within and across product lines. Uses technical, compliance, product, and process knowledge to assist in identifying preventative actions. Able to assure effectiveness of actions are taken to prevent reoccurrence.
    Requirements:
    • 4-year degree (Bachelor's Degree) in a scientific or technical discipline preferred or 10+ years of experience in a related field.
    • 1-3 years in a regulated environment, preferably in medical devices with excellent understating and knowledge of quality system processes.
    • Excellent communication skills, problem solving capability and attention to detail is critical.
    • Knowledge of regulations and standards affecting software development and overall design control for medical devices.
    • Experience in applying quality regulations and standards {e.g., 21CFR 820, ISO 13485, ISO 14971, IEC62304, Cybersecurity- ISO 27001), and working knowledge of current and applicable GMP regulations is required.
    • Use of analytical skills and ability to organize work in a logical and thorough manner.
    • Capable of analysing data to support the development of strategies to effectively manage, enhance, mitigate, and/or resolve potential issues.
    • Challenges data adequacy based on experimental design concepts. Recognizes when issues may have an impact on areas outside of their immediate area of responsibility.
    • Highlights issues in a timely manner and presents possible resolutions. Seeks additional information when problem is beyond area of personal expertise.
    • Experience in reviewing, and executing validation and change control documents, authoring SOPs, Protocols {IQ, OQ, PQ) of Process Control Systems
    • Demonstrates project management skills.
    • Possesses interpersonal skills to negotiate and reconcile differences.
    • Flexibility to adapt to changing assignments and ability to effectively prioritize.
  • Dynomax Inc.

    Quality Engineer

    1 week ago

    Dynomax Inc. Arlington Heights, United States

    QUALITY ENGINEER · Dynomax, Inc is expanding We are adding brand new, state of the art CNC Machines. With the additional machines and projects, maintaining quality is a priority. The Quality Engineer will be responsible for driving 6-Sigma projects, as well as other functions. Qu ...

  • Dynomax Inc.

    Quality Engineer

    3 days ago

    Dynomax Inc. Arlington Heights, United States

    QUALITY ENGINEER · Dynomax, Inc · is expanding We are adding brand new, state of the art CNC Machines. With the additional machines and projects, maintaining quality is a priority. The · Quality Engineer · will be responsible for driving 6-Sigma projects, as well as other functio ...

  • Intertek

    Quality Engineer

    3 days ago

    Intertek Arlington Heights, United States

    Job Description · We are seeking a Quality Engineer to join our Business Assurance team. This will be a full-time remote/home-based position. Duties: - Technical review of aerospace reports, data, and records, both in iEnable and OASIS. - Responsible for certificate review and i ...

  • Dynomax

    Quality Engineer

    39 minutes ago

    Dynomax Arlington Heights, United States

    QUALITY ENGINEER · Dynomax, Inc is expanding We are adding brand new, state of the art CNC Machines. With the additional machines and projects, maintaining quality is a priority. The Quality Engineer will be responsible for driving 6-Sigma projects, as well as other functions. Qu ...

  • Intertek

    Quality Engineer

    4 days ago

    Intertek Arlington Heights, United States

    Job DescriptionWe are seeking a Quality Engineer to join our Business Assurance team. This will be a full-time remote/home-based position. Duties: - Technical review of aerospace reports, data, and records, both in iEnable and OASIS. - Responsible for certificate review and issue ...

  • Sterling Engineering

    Quality Engineer

    1 week ago

    Sterling Engineering Elk Grove Village, United States

    Title: Quality Engineer · Location: Elk Grove Village, IL · Compensation: $85-95K/year · Hire Type: Direct Hire · Job Summary: · We are looking for a Quality Engineer to join our team in Elk Grove Village, IL. This role involves ensuring product quality and compliance through eff ...

  • Sterling Engineering

    Quality Engineer

    1 week ago

    Sterling Engineering Elk Grove Village, United States

    Title: Quality Engineer · Location: Elk Grove Village, IL · Compensation: $75k-85k/year · Hire Type: Direct Hire · We are looking for an experienced Quality Engineer for a manufacturer of complex precision machined components in Elk Grove Village, IL. We are ideally looking for s ...

  • Medline Industries

    Associate Quality Engineer

    1 day ago

    Medline Industries Arlington Heights, United States

    EducationTypically requires a Bachelor%26rsquo;s degree in Engineering, Science, Math or other related technical field. · Knowledge / Skills / AbilitiesExperience in processing all relevant details, understanding and prioritizing their importance, and drawing clear and concise co ...

  • Dynomax Inc.

    Quality Engineer

    1 week ago

    Dynomax Inc. Arlington Heights, United States

    Job Description · QUALITY ENGINEER · Dynomax, Inc is expanding We are adding brand new, state of the art CNC Machines. With the additional machines and projects, maintaining quality is a priority. The Quality Engineer will be responsible for driving 6-Sigma projects, as well as o ...

  • Dynomax

    Quality Engineer

    2 weeks ago

    Dynomax Arlington Heights, United States

    QUALITY ENGINEER · Dynomax, Inc is expanding We are adding brand new, state of the art CNC Machines. With the additional machines and projects, maintaining quality is a priority. The Quality Engineer will be responsible for driving 6-Sigma projects, as well as other functions. Qu ...

  • Intertek

    Quality Engineer

    1 week ago

    Intertek Arlington Heights, United States

    Job DescriptionWe are seeking a Quality Engineer to join our Business Assurance team. This will be a full-time remote/home-based position. Duties: - Technical review of aerospace reports, data, and records, both in iEnable and OASIS. - Responsible for certificate review and issue ...

  • Weber-Stephen Products LLC

    software quality assurance engineer

    3 days ago

    Weber-Stephen Products LLC Palatine, United States

    At Weber, grilling is a passion that's reflected in everything we do. Our goal is to share this passion and spark inspiration with the people who matter most – our grilling community. Weber has been the world's premiere manufacturer of charcoal and gas grills and accessories sinc ...

  • Aurora Ventures

    Quality Engineer

    1 week ago

    Aurora Ventures Cook, United States

    Connecting people and technologies, creating the perfect match for our clients, and always finding the right experts for each challenge - that is our goal at FERCHAU and we are looking for you: an ambitious colleague who, like us, wants to take technologies to the next level. We ...

  • Sterling Engineering Inc.

    Quality Engineer

    1 week ago

    Sterling Engineering Inc. Elk Grove Village, United States

    Job Description · Job DescriptionTitle: Quality Engineer · Location: Elk Grove Village, IL · Compensation: $85-95K/year · Hire Type: Direct Hire · Job Summary: · We are seeking a Quality Engineer to join our team in Elk Grove Village, IL. The Quality Engineer will be responsible ...

  • Magnetic Inspection Laboratory

    Quality Engineer

    3 weeks ago

    Magnetic Inspection Laboratory Elk Grove Village, United States

    Job Type Full-timeDescriptionAt MIL, we make the complex simple; we bring together the brightest minds and subject matter experts to process precision parts that become components on space, aircraft, and defense systems. The reliability of what we do and how we do it, makes the d ...

  • Sterling Engineering

    Quality Engineer

    2 weeks ago

    Sterling Engineering Elk Grove Village, United States

    Job Description · Title: Quality Engineer · Location: Elk Grove Village, IL · Compensation: $85-95K/year · Hire Type: Direct Hire · Job Summary: · We are seeking a Quality Engineer to join our team in Elk Grove Village, IL. The Quality Engineer will be responsible for ensuri ...

  • Tramec

    Quality Engineer

    3 weeks ago

    Tramec Elk Grove Village, United States

    Tramec Plastics and Composites, a division of Tramec Holdings is currently seeking an Operations Associate for their molding operations located in Elk Grove Village, IL. · Tramec Plastics and Composites is a part of the Tramec Holdings family, which has facilities located throu ...

  • LHH Recruitment Solutions

    Quality Engineer

    6 days ago

    LHH Recruitment Solutions Elk Grove Village, United States

    Job Description · Job DescriptionLHH is actively seeking a Director of Quality Assurance for a manufacturing company located in the Elk Grove Village area. This role is responsible for verifying raw material quality as well as finished product quality and will be leading a team o ...

  • Matlen Silver

    Manufacturing Quality Engineer

    3 weeks ago

    Matlen Silver Buffalo Grove, United States

    Manufacturing Quality Engineer · Salary: $40 - $ 45 per hour hr) shifts onsite in Buffalo Grove, IL · Day Shift. - Hours are 7 a - 5 p (overtime paid) · Experience and a thorough understanding of the following manufacturing principles are a MUST for the right candidate to have. ...

  • Ventura Solutions LLC

    Quality Control Engineer

    1 week ago

    Ventura Solutions LLC Des Plaines, United States

    Are you a Quality Control Engineer with experience in the pharmaceutical industry, looking for an exciting opportunity with a consulting firm? If so, we want to hear from you · Ventura Solutions is a trusted medical device and pharmaceutical staffing, consulting, and training fir ...