Jobs
>
Andover

    Quality Engineer Medical Device - Andover, United States - Connexion Systems & Engineering

    Connexion Systems & Engineering
    Connexion Systems & Engineering Andover, United States

    3 weeks ago

    Default job background
    Description
    Job Description

    Job Description

    Quality Engineer

    ESSENTIAL FUNCTIONS INCLUDE BUT ARE NOT LIMITED TO:
    Provide quality engineering support in the manufacturing of medical devices & hardware.
    Ensure compliance of manufacturing processes and areas to all applicable quality system regulations

    Lead Nonconformance (NCMR) process such as inspection methods, containment, correction, closure and CAPAs, and drive continuous improvement through analysis of trend data.

    Monitor and analyze production information to support risk management and to provide direction for corrective and preventive actions and/or process improvement activities.

    Work with manufacturing engineering to ensure necessary process controls and validations are in place and best practices are followed (GMP)

    Support the inspection & testing of raw materials, components & finished products to ensure compliance with specifications & quality standards.

    Resolve incoming inspection yield issues by driving tighter vendor process capabilities, ensuring appropriate internal drawing specifications, and validation of inspection methods.

    Lead analysis of defective components found in Incoming Inspection and work with suppliers to resolve (SCARs)
    Support internal auditing requirements in manufacturing to ensure compliance with quality system requirements.

    BACKGROUND AND QUALIFICATIONS:
    Minimum of 5 years' experience in a Manufacturing Quality and/or Manufacturing Engineering role
    Working knowledge of

    Medical Device Regulations:

    FDA 21 CFR 820, ISO 14971 & 13485 as well other applicable regulations and industry standards pertaining to Medical Devices.

    Experience with manufacturing of complex products in an Environmentally controlled area. Experience with medical capital equipment and electromechanical devices preferred.
    Experience with formal problem-solving methodologies and deductive skills, root cause analysis & CAPA.
    Experience with handling non-conforming material and assemblies.
    Practical knowledge and experience using Minitab or other statistical analysis tools. Understanding & application of Gage R&R and Measurement system analysis desired.
    Utilization of statistical data analysis for trending purposes; ideally Six Sigma methods and tools

    EDUCATION:
    ·

    BS in Mechanical, Electrical, or Biomedical Engineering or other scientific or related discipline

    Company Description Connexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike.

    We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.

    Company Description


    Connexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike.

    We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.

    #J-18808-Ljbffr
  • Cambridge Interventional

    Medical Device

    6 days ago

    Cambridge Interventional Burlington, United States

    Regulatory Affairs and Quality Assurance Manager · Cambridge Interventional is seeking a Manager of RA/QA. Cambridge Interventional is a medical device manufacturer committed to advancing interventional cancer therapy through research, engineering, high-quality products, and phys ...

  • INTELLECTT INC

    Senior Electrical Engineer(Medical devices)

    1 week ago

    INTELLECTT INC Andover, United States

    Role: Hardware Electrical Engineer I · Location: Irvine, CA/ San Diego, CA · Duration: 6 Months · The position of Engineer, R&D-(Electrical Engineer-Hardware) is a technical engineering role focused on supporting the on-market products manufactured within Abbotts Toxicology (T ...

  • Teleflex

    Medical Device

    18 hours ago

    Teleflex Chelmsford, United States

    Expected Travel: None · Requisition ID: 9998 · About Teleflex Incorporated · Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation - a relentless pursuit of id ...

  • Teleflex

    Medical Device

    2 weeks ago

    Teleflex Chelmsford, United States

    Expected Travel: NoneRequisition ID: 9999About Teleflex IncorporatedTeleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation - a relentless pursuit of identifying un ...

  • Exergen Corporation

    Medical Device Product Manager

    2 weeks ago

    Exergen Corporation Watertown, United States

    _**Exergen Corporation**_ _is the recognized world leader in medical non-invasive temperature technology. Exergen invented and manufactures non-invasive temperature measurement devices providing lower cost, higher accuracy, less invasiveness, and greater reliability than ever pre ...

  • Fresenius Kabi AG

    Principal Engineer Software, Medical Device

    3 weeks ago

    Fresenius Kabi AG North Andover, United States

    Job Summary · The Principal Engineer, Software ClinApp designs and implements Fresenius-Kabi software applications to achieve product functionality needs and business objectives. · Responsibilities · Under minimal guidance performs, design and develops software applications an ...

  • Access Vascular

    Medical Device Operator

    2 weeks ago

    Access Vascular Billerica, United States

    Job Description · Job DescriptionAccess Vascular, Inc seeks an operator to add to their quickly growing team to work 1st shift. The right candidate will be responsible for the detailed assembly and production of high quality medical devices within manufacturing. This position inc ...

  • Intellectt Inc

    Senior Electrical Engineer(Medical devices)

    1 week ago

    Intellectt Inc Andover, United States

    Role: Hardware Electrical Engineer I · Location: Irvine, CA/ San Diego, CA · Duration: 6 Months · The position of Engineer, R&D-(Electrical Engineer-Hardware) is a technical engineering role focused on supporting the on-market products manufactured within Abbott's Toxicology (TOX ...

  • Teleflex

    Medical Device

    3 weeks ago

    Teleflex Chelmsford, United States

    Medical Device Assembler-10001 · Date: Apr 28, 2024 · Location: Chelmsford, MA, US · Company: Teleflex · Expected Travel : None · Requisition ID :10001 · About Teleflex Incorporated · Teleflex is a global provider of clinically effective medical technologies designed to improve t ...

  • Cytrellis Biosystems Inc

    Medical Device Verification

    2 weeks ago

    Cytrellis Biosystems Inc Woburn, United States

    Job Description · Job Description Salary: · We're HIRING · Medical Device Test Engineer · We're looking for passionate and ambitious individuals to join the Cytrellis Team · What makes Cytrellis different: · Unique product offering – ellacor by Cytrellis is the FIRST and ONLY ...

  • Cytrellis Biosystems

    Medical Device Verification

    3 weeks ago

    Cytrellis Biosystems Woburn, United States

    Job Description · Job DescriptionSalary: · We're HIRING Medical DeviceVerification & Validation Engineer · We're looking for passionate and ambitious individuals to join the Cytrellis Team · What makes Cytrellis different: · Unique product offering – ellacor by Cytrellis is the ...

  • Teleflex

    Medical Device Assembler

    3 weeks ago

    Teleflex Chelmsford, United States

    Expected Travel: None · Requisition ID: 9976 · About Teleflex Incorporated · Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation - a relentless pursuit of ident ...

  • Teleflex

    Medical Device Assembler

    3 weeks ago

    Teleflex Chelmsford, United States

    Expected Travel: None · Requisition ID: 9967 · About Teleflex Incorporated · Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation - a relentless pursuit of ident ...

  • Teleflex

    Medical Device Assembler

    3 weeks ago

    Teleflex Chelmsford, United States

    Expected Travel: None · Requisition ID: 9962 · About Teleflex Incorporated · Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation - a relentless pursuit of ident ...

  • REOS Sales & Service

    Medical Device Field Service Technician

    3 weeks ago

    REOS Sales & Service Boston, United States

    Duties: · - Service and install SPD equipment (washers, sterilizers, autoclaves, etc.), Surgical Lighting/Booms & OR Surgical Tables. · - Perform troubleshooting, repairs, and maintenance on equipment. · - Provide support to various hospitals within New England. · - Establish and ...

  • embecta

    Medical Device-Senior Electrical Engineer

    21 hours ago

    embecta Andover, United States

    embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more informat ...

  • Teleflex

    Medical Device

    1 week ago

    Teleflex Chelmsford, United States

    Expected Travel: None · Requisition ID: 9999 · About Teleflex Incorporated · Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation - a relentless pursuit of id ...

  • Teleflex

    Medical Device

    2 weeks ago

    Teleflex Chelmsford, United States

    Expected Travel: NoneRequisition ID: 9997About Teleflex IncorporatedTeleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation - a relentless pursuit of identifying un ...

  • Gradient

    Medical Device Toxicologist

    2 weeks ago

    Gradient Boston, United States

    Job Description · Job DescriptionGradient, an environmental consulting firm, is seeking a high energy individual to assist colleagues and clients in toxicological risk assessments and biological safety evaluations for medical devices. · Excellent benefits, friendly, hybrid work e ...

  • Medsurg Sales Staffing

    Medical Device Sales

    2 weeks ago

    Medsurg Sales Staffing Boston, United States

    Job Description · Job DescriptionBlue chip company seeking experienced surgical/medical sales reps.Calling on 2 specialty types of Surgeons in the hospital.Territory is Boston based covering surrounding New England States.Base salary is 45k and plan 135k. Top reps earn 200k plus. ...