Quality Engineer 1

3 weeks ago


Bloomington, United States Cook Group Full time
Overview

The Quality Engineer at Cook Inc. serves as the lead quality representative of certain product lines within product development, manufacturing, post-market surveillance, and/or CAPA.

Responsibilities

• Perform work per external and internal quality standards• Interface with internal and external groups on quality-related issues• Support product development and transfer to manufacturing• Facilitate development and implementation of production controls (e.g. qualification, process capability, sampling plans, validation, etc.)• Perform investigation of product nonconformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues• Plan, review, and approve change requests• Execute risk assessment as needed and facilitate development and completion of risk file documentation• Conduct Risk-based decision making and effective resolution of issues• Lead or support CAPAs as necessary

• May interface with internal or 3rd party audits (e.g. FDA, Notified Body, etc.)• Drive continuous improvement efforts through facilitating, leading, and collaborating with cross function teams including quality, engineering, production, clinical, and regulatory affairs.• Provide leadership in the understanding of medical device regulations and best practices• Manage conflict resolution as it relates to technical situations• Must work and interact effectively and professionally with and for others throughout various levels of the organization• Must strictly adhere to safety requirements

Qualifications

• Bachelors degree in a engineering• Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971)• Professional certification (e.g. ASQ, Six Sigma, etc.) preferred• Proficiency in statistical, quality and continuous improvement methods and tools

• Proficiency in the Microsoft Office suite of products (Word, Excel, PowerPoint, and Outlook) is required.• Strong organizational skills• Critical thinking and attention to detail required• Excellent verbal communication skills and technical writing

Physical Requirements:

• Works under general office environmental conditions, including time in manufacturing environment and biohazard lab• Sitting for extended periods, utilizes close visual acuity for working withcomputers, equipment, etc.• Occasional travel may be required



  • Bloomington, United States Cook Group Full time

    Overview The Quality Engineer at Cook Inc. serves as the lead quality representative of certain product lines within product development, manufacturing, post-market surveillance, and/or CAPA. Responsibilities • Perform work per external and internal quality standards• Interface with internal and external groups on quality-related issues• Support...


  • Bloomington, United States Cook Medical Full time

    Overview The Quality Engineer, Post Market at Cook Incorporated serves as the lead quality representative of certain product lines within product development, manufacturing, post-market surveillance, and/or CAPA. Responsibilities • Perform work per external and internal quality standards• Interface with internal and external groups on quality-related...


  • Bloomington, United States Cook Group Full time

    Overview The Manufacturing Engineer 1 plans, directs, and coordinates manufacturing processes for medical device products, and supports Operations in a way to assure a quality product is produced in a timely manner. The Production Engineer works with Operations, Quality Assurance and Regulatory Affairs to improve existing product designs and processes to...


  • Bloomington, United States Cook Group Full time

    Overview: The Manufacturing Engineer 1 plans, directs, and coordinates manufacturing processes for medical device products, and supports Operations in a way to assure a quality product is produced in a timely manner. The Production Engineer works with Operations, Quality Assurance and Regulatory Affairs to improve existing product designs and processes to...

  • Quality Engineer

    2 weeks ago


    Bloomington, United States Kelly Services Full time

    Job DescriptionKelly® Engineering has exciting Quality Engineer project (6-8 months) with a global industry leader in Bloomington, IN. This position offers a hybrid work schedule of 1 day a week onsite, competitive compensation and the opportunity to work with impactful products.Quality Engineer Responsibilities:\tQuality oversight and approvals for change...

  • Quality Engineer

    2 weeks ago


    Bloomington, United States Kelly Services Full time

    Job DescriptionQuality Engineer (Bloomington, Indiana)Kelly Engineering has exciting Quality Engineering Contract role (6-8 months plus) with a global industry leader in Bloomington, IN. This position offers a hybrid work schedule of 1 day a week onsite, competitive compensation and the opportunity to work with impactful products.Quality Engineers we have...

  • Supplier Engineer 1

    4 weeks ago


    Bloomington, United States Cook Group Full time

    Overview The Supplier Engineer plans, directs, and leads activities that support supplier controls and manufacturing processes for medical device products. Responsibilities - Coordinate with cross-functional teams to create and execute change plans for supplier-related changes in compliance with the Cook Quality Management System and global regulatory...


  • Bloomington, United States Cook Medical Full time

    Overview The Manufacturing Quality Engineer serves as the lead quality representative of assigned product lines for new product development, day to day manufacturing support, non-conformance, and acts as the independent review function. The Manufacturing Quality Engineer supports additional process such as Supplier Quality, Internal Audit, CAPA, and Post...


  • Bloomington, United States Simtra BioPharma Solutions Full time

    Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes,...


  • Bloomington, Indiana, United States Akkodis Full time

    **About Us**Akkodis is a leading provider of engineering services in the medical device industry.We are seeking a highly skilled Validation Engineer to join our team.The ideal candidate will have a Bachelor's degree in Mechanical or Biomedical Engineering and 3+ years of experience in test method validation and process validation.As a Validation Engineer,...


  • Bloomington, United States FMS Full time

    Company Description FMS Corporation is a precision manufacturer of high-performance sintered metal components. The company serves various industries, including off-road vehicles and aerospace. FMS offers design assistance and production capabilities such as in-house tool design, compaction, sintering, CNC machining, and more. Role Description This is a...


  • Bloomington, United States FMS Corporation Full time

    Company DescriptionFMS Corporation is a precision manufacturer of high-performance sintered metal components. The company serves various industries, including off-road vehicles and aerospace. FMS offers design assistance and production capabilities such as in-house tool design, compaction, sintering, CNC machining, and more.Role DescriptionThis is a...


  • Bloomington, United States FMS Corporation Full time

    Company DescriptionFMS Corporation is a precision manufacturer of high-performance sintered metal components. The company serves various industries, including off-road vehicles and aerospace. FMS offers design assistance and production capabilities such as in-house tool design, compaction, sintering, CNC machining, and more.Role DescriptionThis is a...


  • Bloomington, United States Cook Group Full time

    Overview The Quality Engineer serves as the quality mentor and/or reviewer for all CAPA and RIC activities. Responsibilities • Perform work per external and internal quality standards• Interface with internal and external groups on quality-related issues• Conduct Risk-based decision making and effective resolution of issues• May interface with...


  • Bloomington, United States General Dynamics Mission Systems Full time

    Basic Qualifications Requires a Bachelor‘s degree in Engineering, or a related Science or Mathematics field. Also requires 5+ years of job-related experience, or a Master‘s degree plus 3 years of job-related experience.CLEARANCE REQUIREMENTS:Department of Defense Secret security clearance is preferred at time of hire. Candidates must...

  • Quality Associate 1

    4 weeks ago


    Bloomington, United States Singota Solutions Full time

    Job Description Job Description # JD141 Job title: Quality Associate 1 - Operations Department: Quality Assurance and Regulatory Affairs Position Type: Full-time, exempt (Onsite) Reports to: Quality Assurance Supervisor General Description: The Quality Associate 1-Operations position provides Quality oversight, assistance and guidance in daily operations...


  • Bloomington, United States Cook Medical Full time

    Overview The Quality Engineer serves as the quality mentor and/or reviewer for all CAPA and RIC activities. Responsibilities • Perform work per external and internal quality standards• Interface with internal and external groups on quality-related issues• Conduct Risk-based decision making and effective resolution of issues• May interface with...


  • Bloomington, Indiana, United States Cook Group Full time

    Overview:Cook Group is seeking a highly experienced and skilled Senior Quality Engineering Manager to lead our Post Market Quality Engineering team. The ideal candidate will have a strong background in quality engineering, with a proven track record of delivering high-quality results and mentoring team members.Responsibilities:Provide technical direction for...


  • Bloomington, United States Cook Group Full time

    Overview The Manufacturing Quality Engineer serves as the lead quality representative of assigned product lines for new product development, day to day manufacturing support, non-conformance, and acts as the independent review function. The Manufacturing Quality Engineer supports additional process such as Supplier Quality, Internal Audit, CAPA, and Post...


  • Bloomington, United States Onto Full time

    Onto Innovation is a leader in process control, combining global scale with an expanded portfolio of leading-edge technologies that include: 3D metrology spanning the chip from nanometer-scale transistors to micron-level die-interconnects; macro defect inspection of wafers and packages; metal interconnect composition; factory analytics; and lithography for...