Manufacturing Quality Engineer 2

3 weeks ago

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 Market Surveillance. The Manufacturing Quality Engineer fulfills the role of both contributor and independent reviewer for their assigned product lines.

Responsibilities:

- Perform work per external and internal quality standards.
- Perform independent review function per external and internal quality standards.
- Interface with internal and external groups on quality-related issues.
- Be the voice of quality for daily manufacturing in assigned departments by partnering with Operations and Production Engineering and providing guidance on issues in line with external standards, internal standards, and best practices.
- Support product development and transfer to manufacturing.
- Facilitate development and implementation of production processes and controls. (e.g. qualification, process capability, sampling plans, validation, etc.)
- Assist with investigation of product non-conformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues.
- Own quality improvement tasks in assigned departments.
- Plan, draft, and route change requests as necessary.
- Execute risk assessment as needed and facilitate development and completion of risk file documentation.
- 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 engineering, production, clinical, and regulatory affairs.
- Provide leadership in the understanding of medical device regulations and best practices.
- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
- Adhere to the Quality Management System and its processes to ensure compliance to FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

Qualifications:

- Bachelors degree in engineering
- Knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971) is preferred but will consider a candidate with quality experience from any regulated industry.
- 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.

  • Manufacturing Quality Engineer 2

    2 weeks ago

    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...

  • Manufacturing Engineer 2

    3 weeks ago

    Bloomington, United States Cook Group Full time

    Overview: The Manufacturing Engineer 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...

  • Manufacturing Engineer I

    3 weeks ago

    Bloomington, United States Quality Tech Services, LLC Full time

    Overview About QTS QTS offers critical end-of-line services for medical device OEMs including finished device assembly, packaging and sterilization management. QTS is part of the Cretex Medical family of companies. Learn more at www.qtspackaging.com and www.cretexmedical.com. Manufacturing Engineer Ideal Candidate Profile QTS is currently seeking an...

  • Manufacturing Engineer 2, Controls

    4 weeks ago

    Bloomington, United States Cook Full time

    The primary purpose of this position is to provide technical support to Production and Manufacturing Engineering. In addition, drive process improvements to increase Manufacturing efficiency plus further develop manufacturing activities within the pl Manufacturing Engineer, Controls, Manufacturing, Technical Support, Engineer, Equipment

  • Manufacturing Quality Manager

    4 days ago

    Bloomington, United States Hidden Full time

    Job DescriptionJob DescriptionTitle: Quality Manager (Manufacturing)Location: Bloomington, IN Job Summary:The Quality Manager is a crucial part of the manufacturing operations site leadership team, reporting directly to the Plant and Operations Manager. Our distinctive design capabilities allow us to offer top-tier, industry-leading solutions. This role...

  • Manufacturing Engineer

    4 weeks ago

    Bloomington, United States Intellectt Inc Full time

    Title: Manufacturing Engineer/CastingsLocation: Bloomington, Minnesota - OnsiteFulltimeRequired: Casting (casting molds, cores, and tooling), quality controls, CAD/CAMJob Description & Skill Requirement:This position is for an experienced Aerospace Sand Casting Expert role to join a growing aerospace. As an important part of the Mechanical team here, you...

  • Manufacturing Engineer

    4 weeks ago

    Bloomington, United States Intellectt Inc Full time

    Title: Manufacturing Engineer/CastingsLocation: Bloomington, Minnesota - OnsiteFulltimeRequired: Casting (casting molds, cores, and tooling), quality controls, CAD/CAMJob Description & Skill Requirement:This position is for an experienced Aerospace Sand Casting Expert role to join a growing aerospace. As an important part of the Mechanical team here, you...

  • Manufacturing Engineer

    4 weeks ago

    Bloomington, United States Intellectt Inc Full time

    Title: Manufacturing Engineer/CastingsLocation: Bloomington, Minnesota - OnsiteFulltimeRequired: Casting (casting molds, cores, and tooling), quality controls, CAD/CAMJob Description & Skill Requirement:This position is for an experienced Aerospace Sand Casting Expert role to join a growing aerospace. As an important part of the Mechanical team here, you...

  • Manufacturing Engineer

    3 days ago

    Bloomington, United States PrideStaff Full time

    Electronics Manufacturer in Bloomington is hiring an entry level Manufacturing Process Engineer! Full Time | First Shift | $20-$25/hr. The position provides technical assistance for operators in the refinement and control of processes. Responsibili Manufacturing Engineer, Manufacturing, Process Engineer, Engineer, Staffing

  • Senoir Manufacturing Engineer

    2 weeks ago

    Bloomington, Indiana, United States CIRCOR International, Inc Full time

    Senior Engineer ManufacturingORGANIZATIONAL STRUCTUREBUSINESS: IndustrialLOCATION: Monroe, NCDIRECT REPORTING: Sr Manufacturing Engineering ManagerFUNCTIONAL REPORTING: Engineering/Manufacturing POSITION DETAILS - Sr Manufacturing EngineerPosition SummaryThe Sr Manufacturing Engineer position works collectively with other functional groups including...

  • Senoir Manufacturing Engineer

    1 week ago

    Bloomington, Indiana, United States CIRCOR International, Inc Full time

    Senior Engineer ManufacturingORGANIZATIONAL STRUCTUREBUSINESS: IndustrialLOCATION: Monroe, NCDIRECT REPORTING: Sr Manufacturing Engineering ManagerFUNCTIONAL REPORTING: Engineering/Manufacturing POSITION DETAILS - Sr Manufacturing EngineerPosition SummaryThe Sr Manufacturing Engineer position works collectively with other functional groups including...

  • Quality Engineering Intern

    1 month ago

    Bloomington, United States Cook Group Full time

    Overview: The Quality Engineering Intern may be involved in projects in the following areas: Quality Engineering, Supplier Quality Engineering, Process Validation, CAPA/ Complaint, Metrology, Inspection Methods, Test Method Validation, or Polymer Engineering. This position is a 12-week paid internship located in Bloomington, Indiana. In addition to their...

  • ENG Manufacturing Engineer I

    7 days ago

    Bloomington, Indiana, United States Volt Full time

    Volt is immediately hiring a Manufacturing Engineer in Monroe, NC for a well-known industry leader. In this role you will have the opportunity to collaborate with some of the most innovative and diverse people around the world. This is a first shift position. As a Manufacturing Engineer you will:Lead SAP bill of material creation, recipe creation and...

  • Quality Engineer

    3 weeks ago

    Bloomington, United States General Dynamics Mission Systems Full time

    Basic Qualifications Bachelor’s degree in Engineering, a related specialized area or field, or equivalent experience is required. CLEARANCE REQUIREMENTS: Department of Defense Secret security clearance is required within a reasonable period of time. Applicants selected will be subject to a U.S. Government security investigation and must meet eligibility...

  • Manufacturing Engineer with Casting Experience

    3 weeks ago

    Bloomington, United States INTELLECTT INC Full time

    Title: Manufacturing Engineer/CastingsLocation: Bloomington, Minnesota - OnsiteRequired: Casting (casting molds, cores, and tooling), quality controls, CAD/CAMJob Description & Skill Requirement:This position is for an experienced Aerospace Sand Casting Expert role to join a growing aerospace. As an important part of the Mechanical team here, you will...

  • Senior Engineer, Manufacturing Science and Technology

    2 weeks ago

    Bloomington, United States Catalent Pharma Solutions Full time

    Senior Engineer, Manufacturing Science and Technology (MS&T)Job SummaryCatalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier...

  • Senior Engineer, Manufacturing Science and Technology

    1 week ago

    Bloomington, United States Catalent Pharma Solutions Full time

    Senior Engineer, Manufacturing Science and Technology (MS&T)Job SummaryCatalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier...

  • Senior Quality Assurance Engineer

    4 weeks ago

    Bloomington, United States SkyWater Technology Foundry Full time

    SkyWater is looking for a Quality Assurance Senior Engineer for supplier management, cost reduction, and support new product introduction. Responsibilities: Manages assigned Suppliers through the review of Supplier performance data, communication of Supplier performance with Supplier, driving improvements in Supplier's delivered Quality, evaluation and...

  • Quality Engineer

    3 weeks ago

    Bloomington, Indiana, United States Hitachi Careers Full time

    Description On January 1, 2021, Hitachi Automotive Systems, Ltd., Keihin Corporation, Showa Corporation and Nissin Kogyo Co., Ltd. merged to form Hitachi Astemo, Ltd., a world-leading mobility solutions provider focusing on advanced mobility technologies within the fields of electrification, autonomous driving, and connectivity to help reduce environmental...

  • Manufacturing Engineer

    4 weeks ago

    Bloomington, IN, United States Altec Group Full time

    Aegis Worldwide Manufacturing Engineer - 1st Shift Bloomington, IN $100k-120k Salary If you are looking for a great company with an awesome company culture, consider this 1st shift Manufacturing Engineer role in the Bloomington, IN area! Aegis Worldwide is partnered with a top tier manufacturer in Bloomington, IN! We are looking for engineers that are...