Jobs
>
New York City

    Quality Engineer III - New York, United States - Integer Holdings Corporation

    Integer Holdings Corporation
    Integer Holdings Corporation New York, United States

    1 day ago

    Default job background
    Description

    Quality Engineer III: The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance. Provide work direction for 3-5 Technicians/Inspectors.

    Apply (by clicking the relevant button) after checking through all the related job information below.

    • Adheres to Integer Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
    • Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
    • Monitors manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.
    • Leads and implements various product and process improvement methodologies.
    • Review the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
    • Leads in the completion and maintenance of risk analysis.
    • Leads generation and completion of protocols and reports for test method validations.
    • Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.
    • Develops various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.
    • Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
    • Effectively communicate and interact with customers.
    • Leads and manage complaint investigations.
    • Acts as a lead in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
    • Assists with product transfers.
    • Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Also, leads each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.
    • Provides support to other quality engineers.
    • Performs other functions as required.

    Minimum Education: Bachelor's Degree in Engineering or related field required.

    Minimum Experience: 5-7 years' experience in medical device or regulated manufacturing

    Specialized Knowledge: Competence in the selection and use of Quality Engineering Tools and Techniques. Good knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.) Proficient in Microsoft Office and Minitab Special Skills: Ability to work independently and in team environment. Ability to effectively communicate written and verbally. Ability to manage time effectively to ensure timely completion of tasks. Knowledge of SPC, FMEA, DOE, RCA, GDT Sound knowledge of quality management systems.

    Other: Certified Quality Engineering (CQE), Certified Software Quality Engineer (CSQE), Certified Reliability Engineer (CRE), Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), or Six Sigma Green Belt or Black Belt desired.

  • JobRialto

    Engineer III

    1 week ago

    JobRialto New York, United States

    Locations - New York, Sandy (UT), Sunrise (FL), Phoenix (AZ) · Description · Focus Contributes to analysis of business, application, and technical infrastructure requirements of the Meeting Technology Team. · Supports the design, build, improvement and integration of infrastru ...

  • Acquired Data Solutions

    Engineer III

    2 days ago

    Acquired Data Solutions Atlantic City, United States

    Job Description · Job DescriptionMUST HAVE CURRENT DHS SUITABILITY OR CURRENT SECRET CLEARANCE AT OTHER GOVERNMENT AGENCIES. · Mid Level (6-12 years experience) · Acquired Data Solutions, Inc. is a test and engineering company that is seeking an onsite Mid Level Engineer to join ...

  • Capital Staffing Solutions

    Systems Engineer III

    3 days ago

    Capital Staffing Solutions New York, United States

    Systems Engineer III · HYBRID – Two days onsite in Melbourne or Miramar, FL · 6-Month Contract-to-Hire · Seeking a candidate that can automate deployment functions · Must be able to create scripts and troubleshoot scripts (more experience is better) vs someone that only knows h ...

  • Strata Clean Energy

    Electrical Engineer III

    5 days ago

    Strata Clean Energy New York, United States

    Strata Clean Energy is a leading developer, EPC, and service provider for utility-scale solar and storage systems in the United States. We control and self-perform all processes from our nationwide solar and storage developments, to construction, O&M, and Asset Management. · Our ...

  • PSG Global Solutions

    Systems Engineer III

    5 days ago

    PSG Global Solutions New York, United States

    We're looking for a · Systems Engineer III , working in · Pharmaceuticals · and · Medical Products · industry in · 55 Corporate Drive, Bridgewater, New Jersey, 08807, United States . · Job description: · Supports the increasing need of collaboration with outside companies ...

  • E.E. Cruz & Company, Inc.

    Field Engineer III

    3 days ago

    E.E. Cruz & Company, Inc. New York, United States

    Field Engineer III · Job Locations US-NY-White Stone · Requisition ID · Category Engineering · Position Type Experienced Professional · Division : Name EE Cruz & Co Inc. · Employment Status Full-time Regular · Overview · Field Engineer will provide technical engineering informat ...

  • Fanatics

    Software Engineer III

    1 day ago

    Fanatics New York, United States

    Job Description · Overview · As Software Engineer III - Middlewares at Fanatics Betting & Gaming (FBG), you are here to help build out our Data Platform Engineering team. This role reports to our Director of Platform Engineering and is responsible for defining, implementing, tr ...

  • JPMorgan Chase Bank, N.A.

    Software Engineer III

    1 day ago

    JPMorgan Chase Bank, N.A. New York, United States

    We have an exciting and rewarding opportunity for you to take your software engineering career to the next level. · As a Software Engineer III at JPMorgan Chase within Consumer & Community Banking, Product Agility Tools, you serve as a seasoned member of an agile team to design ...

  • CrowdStrike, Inc.

    Network Engineer III

    1 day ago

    CrowdStrike, Inc. N/A, United States

    About the Role: · CrowdStrike is looking for a Senior Network Engineer who has solid track records for building and operating hyper-scale hybrid cloud networks. You will be responsible for deployment and lifecycle of our data center network infrastructure. You will own and drive ...

  • Rightway Inc

    Data Engineer III

    1 week ago

    Rightway Inc New York, United States

    ABOUT THE ROLE: · We are seeking a full-time Data Engineer III to join our team and define and deploy mission-critical data infrastructure. The primary responsibility for this role is defining the processing of large healthcare datasets which enable Rightway to generate insights ...

  • augmentjobs

    Software Engineer III

    1 day ago

    augmentjobs New York, United States

    Job Description · Job DescriptionWe are seeking a skilled and driven Software Engineer III to join our innovative engineering team. The ideal candidate will possess a deep passion for technology, a robust understanding of advanced software development principles, and the capabili ...

  • CrowdStrike, Inc.

    Network Engineer III

    1 day ago

    CrowdStrike, Inc. N/A, N/A, United States

    About the Role: · CrowdStrike is looking for a Senior Network Engineer who has solid track records for building and operating hyper-scale hybrid cloud networks. You will be responsible for deployment and lifecycle of our data center network infrastructure. You will own and drive ...

  • Disco

    Software Engineer III

    2 days ago

    Disco New York, United States

    The Software Architect (UI) are experienced engineers handling complex tasks and contributing significantly to their team's goals. They are expected to start leading small projects or components, while building high-quality software that delivers feature sets to customers and are ...

  • Saxon Global

    Java Engineer III

    1 day ago

    Saxon Global New York, United States

    · • Enterprise data lake (security side) · • Ongoing resiliency work · • Update existing code base to reduce vulnerabilities that exist in current code · • Find ways to clear vulnerabilities while · • Java 11+ · • Database · • API · • Data lake and supporting applications ...

  • CrowdStrike

    Software Engineer III

    1 week ago

    CrowdStrike New York, United States

    About the Role: · Have you spent hours arguing about tabs versus spaces? Does correlating and analyzing data at massive trillions-of-events-per-day scale excite you? Do you care deeply about cybersecurity and want to play an active role in helping to secure organizations from cy ...

  • CrowdStrike, Inc.

    DevOps Engineer III

    2 days ago

    CrowdStrike, Inc. N/A, N/A, United States

    About the Role: · CrowdStrike is hiring a DevOps Engineer to help build and deploy automation and configuration to drive our massive scale. We are looking for a highly-technical, hands-on engineer with experience using configuration management software (Chef & Ansible) to release ...

  • Crossfire Consulting

    OSP Engineer III

    5 days ago

    Crossfire Consulting New York, United States

    2 days per week in the office with possibly more as the needs of the business require. · Targeted Years of Experience: 5-7 years · Responsibilities: · •Copper and Fiber plant design, and general construction knowledge. · •Experience in telecommunications / data networking or wire ...

  • Mackinnon Bruce International

    Engineer I/II or III

    5 days ago

    Mackinnon Bruce International New York, United States

    Mackinnon Bruce International, an Executive Search Consultancy within the global Civil Infrastructure, Water and Wastewater industries, are working exclusively alongside a nationally recognized leader within the Water, Wastewater and Civil Engineering markets, who are looking to ...

  • Beckwood Press Company

    Electrical Controls Engineer III

    5 days ago

    Beckwood Press Company New York, United States

    Opportunity · Electrical Controls Engineer III · Role Summary · An Electrical Controls Engineer III is responsible for designing and implementing control systems used on various types of press machinery. The employee will be accountable for designing industrial control panels co ...

  • Russell Tobin & Associates

    Systems/Software Engineer-III

    8 hours ago

    Russell Tobin & Associates New York, United States

    · What are we looking for in our Systems/Software Engineer-III? · Position: Senior Software Engineer · Location: Remote (EST) · Pay Rate: $90-$110/HR (DOE) · Contract: 6 Months (Extension Likely) · Position Overview: · We are seeking a talented Senior Software Engineer with a st ...