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Quality Engineer
2 weeks ago
Cook Medical Spencer, United StatesOverview · The Quality Engineer at Cook Spencer The Quality Engineer 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 ...
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Quality Manufacturing Engineer
3 weeks ago
Cook Spencer, United StatesThe Quality Manufacturing Engineer at Cook Spencer will spend 50% of their time reviewing quality aspects of product lines, including: involvement in CAPA's, supplier quality and manufacturing quality. The remaining 50% will be spent planning, direct Manufacturing Engineer, Manuf ...
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Quality Engineering Technical Support
1 week ago
Akkodis Spencer, United StatesAkkodis is seeking a Quality Engineering Technical Support for a six plus month onsite contract position with a client located in Spencer, IN. You will work within manufacturing, post-market surveillance, pre-market, Engineering and CAPA in order to document and update quality in ...
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Quality Engineer
3 weeks ago
Cook Spencer, United StatesThe Quality Engineer at Cook Spencer The Quality Engineer serves as the lead quality representative of certain product lines within product development, manufacturing, post-market surveillance, and/or CAPA. Responsibilities - Perform work per externa Quality Engineer, Continuous ...
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Quality Engineering Technical Support
4 days ago
Akkodis Spencer, United StatesAkkodis is seeking a Quality Engineering Technical Support for a six plus month onsite contract position with a client located in Spencer, IN. You will work within manufacturing, post-market surveillance, pre-market, Engineering and CAPA in order to document and update quality in ...
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Quality Manufacturing Engineer
2 weeks ago
Cook Medical Spencer, United StatesOverview · The Quality Manufacturing Engineer at Cook Spencer will spend 50% of their time reviewing quality aspects of product lines, including: involvement in CAPA's, supplier quality and manufacturing quality. The remaining 50% will be spent planning, directing and coordinati ...
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Quality Manufacturing Engineer
1 week ago
Cook Medical Spencer, United StatesOverview · The Quality Manufacturing Engineer at Cook Spencer will spend 50% of their time reviewing quality aspects of product lines, including: involvement in CAPA's, supplier quality and manufacturing quality. The remaining 50% will be spent planning, directing and coordinati ...
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Quality Manufacturing Engineer
1 week ago
Cook Group Spencer, United States PermanentOverview: · The Quality Manufacturing Engineer at Cook Spencer will spend 50% of their time reviewing quality aspects of product lines, including: involvement in CAPA's, supplier quality and manufacturing quality. The remaining 50% will be spent planning, directing and coordinat ...
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Cook Medical Spencer, United States InternshipSHIPOverview · The Fall Engineering Co-op Program is a paid co-op experience located in Spencer, Indiana. We offer a 16 -week rotation with assignments in Sustaining Engineering . This position includes a housing stipend, 401(k), fitness center access, learning events, capstone prese ...
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Cook Medical Spencer, United States InternshipSHIPOverview · The Fall Engineering Co-op Program is a paid co-op experience located in Spencer, Indiana. We offer a 16 -week rotation with assignments in Manufacturing Engineering . This position includes a housing stipend, 401(k), fitness center access, learning events, capstone pr ...
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Sustaining Engineer 2
2 days ago
Cook Medical Spencer, United StatesOverview · Engineer 2, Sustaining, will perform activities related to sustaining commercially available products. These activities may include (but are not limited to) product/process remediation, risk analysis, regulatory approval support, and product/process improvements. The ...
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Research and Development Engineer
2 weeks ago
Cynet Systems Spencer, United StatesJob Description: · Responsibilities: Fully participates in and successfully contributes to project teams typically including the following activities: product design and development, test of materials, preparation of specifications, process capability studies, research investiga ...
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Reliability and Asset Management Engineer
2 weeks ago
Hoosier Energy Spencer, United StatesPay Grade: M07, M08 · POSITION SUMMARY · Monitors and evaluates the performance and condition of power system assets in order to comply with the corporate asset management strategy and ensure necessary investments are made to maintain long-term reliability. Analyzes and reports o ...
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Hoosier Energy Spencer, United StatesPay Grade: M07, M08 · POSITION SUMMARY · Monitors and evaluates the performance and condition of power system assets in order to comply with the corporate asset management strategy and ensure necessary investments are made to maintain long-term reliability. Analyzes and reports ...
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R&D Engineer
3 weeks ago
Veterans Sourcing Group Spencer, United StatesThis person will be working on a new product accessory for a valve replacement device. · Job Purpose · Develops products, materials, processes, or equipment for projects of moderate complexity. · Under limited supervision/guidance, compiles, analyzes, and reports operational, tes ...
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Manufacturing Engineer 1
3 weeks ago
Cook Medical Spencer, United StatesOverview · 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 Assura ...
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Senior Engineer, Sustaining
1 week ago
Cook Medical Spencer, United StatesOverview · Senior Engineer, Sustaining, will perform activities related to sustaining commercially available products. These activities may include (but are not limited to) product/process remediation, risk analysis, regulatory approval support, and product/process improvements. ...
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Senior Engineer, Sustaining
1 week ago
Cook Group Spencer, United States PermanentOverview: · Senior Engineer, Sustaining, will perform activities related to sustaining commercially available products. These activities may include (but are not limited to) product/process remediation, risk analysis, regulatory approval support, and product/process improvements ...
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Process Engineer II
3 weeks ago
Pharmavise Spencer, United StatesJob Description · Job Role: Process Engineer II · Overview: · From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing techni ...
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Process Engineer
3 weeks ago
Apex Systems Spencer, United StatesApex Systems is currently seeking a Process Engineer for one of our top Medical Device clients in Spencer , IN. · Please see below for details about this exciting growth opportunity, and email Lisa at [email protected] asap to learn more · Key Responsibilities · 1. Fully parti ...
Quality Engineer - Spencer, United States - Cook Group
Description
Overview:
The Quality Engineer at Cook Spencer The Quality Engineer 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 non-conformance/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 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 meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
- Must strictly adhere to safety requirements.
- Maintain regular and punctual attendance.
- Must maintain company quality and quantity standards.
- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with
minimal supervision.
- Ability to remain calm and receptive in fast paced situations.
Engineer degree or a Technical Life Science Degree.
- Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO
- 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.
**Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) of this employment position.**
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 with computers, equipment, etc.
- Occasional travel may be required.
Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.