We have other current jobs related to this field that you can find below
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Quality Engineer
3 days ago
Manchester, United States Complete Staffing Full timeQuality Engineer QUALITY ENGINEER COMP – 95K-100K Summary The Quality Engineer assures that the assigned products meet all of the customer purchase orders, drawing and specifications regarding the manufacturing of the assigned hardware. Develop inspection standards, support and guide inspection, manufacturing and Engineering personnel. Perform quality...
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Quality Engineer
3 months ago
Manchester, United States XL Specialized Trailers Full timeCountry:United States of AmericaLocation:XL Specialized Trailers, 1086 South 3rd St., Manchester, Iowa 52057Position Overview:The XL Quality organization is looking for talented candidates to fill a new opening for a Quality Engineer on our QA & Continuous Improvement team. This role will serve as a subject matter experts (SME's) to lead the implementation...
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Quality Engineer
3 months ago
Manchester, United States XL Specialized Trailers Full timeCountry: United States of America Location: XL Specialized Trailers, 1086 South 3rd St., Manchester, Iowa 52057 Position Overview: The XL Quality organization is looking for talented candidates to fill a new opening for a Quality Engineer on our QA & Continuous Improvement team. This role will serve as a subject matter experts (SME's) to lead the...
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Quality Engineer
3 months ago
Manchester, United States XL Specialized Trailers Full timeJob DescriptionJob DescriptionCountry:United States of AmericaLocation:XL Specialized Trailers, 1086 South 3rd St., Manchester, Iowa 52057Position Overview:The XL Quality organization is looking for talented candidates to fill a new opening for a Quality Engineer on our QA & Continuous Improvement team. This role will serve as a subject matter experts...
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Quality Assurance Engineer
5 days ago
Manchester, Connecticut, United States Complete Staffing Full timeQuality EngineerCOMPENSATION: 95K-100KOverviewThe Quality Engineer is responsible for ensuring that the designated products align with all customer purchase orders, specifications, and manufacturing standards. This role involves developing inspection criteria, providing guidance to inspection and engineering teams, and conducting quality audits to monitor...
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Quality Assurance Engineer
6 days ago
Manchester, Iowa, United States XL Specialized Trailers Full timePosition Overview:The XL Specialized Trailers Quality team is in search of qualified candidates for the position of Quality Assurance Engineer. This role is essential in spearheading the execution and improvement of key quality initiatives, including ISO-9001 standards, throughout the organization. As a recognized authority in the field, the Quality...
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Quality Systems Engineer
6 days ago
Manchester, Iowa, United States XL Specialized Trailers Full timePosition Overview:The XL Specialized Trailers Quality team is in search of talented individuals for the position of Quality Engineer. This role is crucial in spearheading the implementation and refinement of strategic quality initiatives, including ISO-9001 standards, within the organization. As a key expert in the field, the Quality Engineer will offer...
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Quality Assurance Engineer
5 days ago
Manchester, Connecticut, United States Complete Staffing Full timeQuality EngineerCOMP – 95K-100KOverviewThe Quality Engineer is responsible for ensuring that the designated products conform to all customer purchase orders, specifications, and drawings associated with the manufacturing of the relevant hardware.Key ResponsibilitiesReview purchase orders, customer specifications, and technical drawings.Collaborate with...
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Quality Assurance Engineer
14 hours ago
Manchester, Iowa, United States XL Specialized Trailers Full timeCompany:XL Specialized TrailersPosition:Quality EngineerThe Quality team at XL Specialized Trailers is looking for talented individuals to fill the role of Quality Engineer within our QA & Continuous Improvement division. In this pivotal position, you will spearhead the execution and refinement of essential processes such as ISO-9001. You will also serve as...
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Quality Assurance Engineer
6 days ago
Manchester, Tennessee, United States Insight Global Full timePosition: Test EngineerLocation: Manchester, TNWork Schedule: Monday to Friday, On-SiteContract Duration: 4 Month Contract (Filling in for a temporary absence)This project has recently been awarded, with potential for extension beyond a year or a permanent role.Compensation: Competitive hourly rate (commensurate with experience) Essential...
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Manchester, United States Courseadvisor Full timeSoftware Quality Assurance Engineer or Tester Life As a Software Quality Assurance Engineer or Tester Example of Software Quality Assurance Engineer or Tester Job : Develop and execute software test plans in order to identify software problems and their causes. A Day in the Life of a Software Quality Assurance Engineer or Tester Coordinate user or...
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Quality Assurance Engineering Specialist
6 days ago
Manchester, New Hampshire, United States Merrimack Manufacturing Full timeMerrimack Manufacturing stands at the forefront of the medical device industry, committed to innovating and improving lives through state-of-the-art products.As a Quality Engineering Technician, you will play a crucial role in our vibrant and fast-paced manufacturing environment.This position is centered around ensuring that all products, processes, and...
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Quality Assurance Engineering Specialist
6 days ago
Manchester, New Hampshire, United States Merrimack Manufacturing Full timeMerrimack Manufacturing stands at the forefront of the medical device industry, committed to innovating and improving lives through state-of-the-art products.As a Quality Engineering Technician, you will play a crucial role in our vibrant and fast-paced manufacturing environment.This position focuses on verifying that all products, processes, and components...
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Quality Assurance Engineering Specialist
6 days ago
Manchester, New Hampshire, United States Merrimack Manufacturing Full timeMerrimack Manufacturing stands at the forefront of the medical device industry, committed to improving lives through innovative solutions. We are a growing organization focused on excellence in our manufacturing processes.As a Quality Engineering Technician, you will play a crucial role in our vibrant and fast-paced environment dedicated to medical device...
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Jr. NPI Quality Engineer
3 months ago
Manchester, United States Merrimack Manufacturing Full timeJob DescriptionJob DescriptionMerrimack Manufacturing is seeking an Jr. NPI Quality Engineer to support design transfer activities and quality operations in an innovative, fast-paced, medical device-manufacturing environment. This role includes generation and maintenance of control plans, risk management files, validation protocols, and other QMS...
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Quality Systems Engineer
3 weeks ago
Manchester, United States DEKA Research & Development Full timeJob DescriptionJob DescriptionJoin our dynamic team at DEKA and be at the forefront of driving quality excellence! As our Quality Systems Engineer, you'll be a key player in our collaborative environment, working hand-in-hand with cross-functional teams to ensure the highest standards of quality and compliance.As a Quality Systems Engineer, you will...
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Quality Systems Engineer
1 month ago
Manchester, United States DEKA Research & Development Full timeJob DescriptionJob DescriptionJoin our dynamic team at DEKA and be at the forefront of driving quality excellence! As our Quality Systems Engineer, you'll be a key player in our collaborative environment, working hand-in-hand with cross-functional teams to ensure the highest standards of quality and compliance.As a Quality Systems Engineer, you will...
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Quality Assurance Engineer
2 weeks ago
Manchester, United States Moore DM Group Full timeDescription As a Quality Assurance Engineer, you'll bring experience with SQL, front-end testing, and the ability to create smoke, functional, and user acceptance tests. You'll be responsible for testing our software applications and ensuring the quality of the software meets the high standards set by our company. This is a full-time, salaried position that...
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Quality Assurance Specialist
5 days ago
Manchester, Connecticut, United States Complete Staffing Full timeQuality EngineerCOMP – 95K-100KOverviewThe Quality Engineer is responsible for ensuring that the designated products comply with all customer purchase orders, specifications, and manufacturing standards. This role involves developing inspection criteria, guiding inspection teams, and collaborating with manufacturing and engineering personnel. The Quality...
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Quality Control Specialist
17 hours ago
Manchester, Iowa, United States XL Specialized Trailers Full timeCompany:XL Specialized TrailersPosition:Quality EngineerThe Quality team at XL Specialized Trailers is on the lookout for talented individuals to join our ranks as a Quality Engineer within the QA & Continuous Improvement division. In this pivotal role, you will spearhead the execution and refinement of strategic initiatives such as ISO-9001. Moreover, you...
Quality Engineer
3 months ago
Sequel Med Tech is an emerging medical device company committed to revolutionizing patient care through innovative solutions. Our mission is to improve the lives of patients by developing cutting-edge medical technologies that address unmet needs in healthcare.
Job Overview
The Quality Engineer will be a key member of our growing Quality/Regulatory team as we build out a robust QMS compliant with FDA and EU regulations. The QE will first contribute in areas immediately being phased in, including document control system implementation, and Market, Legal and Review documentation and approvals. Longer-term phase-in will include responsibilities in all areas of QA and Regulatory activities as we build out our systems.
Job Responsibilities and Essential Duties
- Assist with activities related to controlled documents in the quality management system including document creation, obsolescence, archival, and revisions.
- Review documents for accuracy, completeness, and compliance in accordance with relevant regulations (e.g., ISO 13485, FDA CFR 820).
- As a Documentation Control team member will contribute to supporting the Document Control Manager with implementing Sequel's QMS, MLR process review and approvals, and document control system implementation.
- Support and drive advanced data analysis techniques and reporting tools.
- Provide day-to-day support for Document and Change Control in the electronic QMS
- Assist with internal and external audits. Coordinate/track/drive closure of QMS audit report responses, CAPAs, deviations. Ensure closure and implementation in a timely manner
- Support Nonconformance (NCMR) process such as inspection methods, containment, correction, closure and CAPAs, and drive continuous improvement through analysis of trend data.
- Support analysis of defective components found in Incoming Inspection and work with suppliers to resolve through the SCAR process.
- Compile and present quality issues and KPI to cross functional teams in a concise and clear manner.
- Work independently and within teams.
- Travel required up to 20% including some international.
- Bachelor's degree in a STEM area.
- Experience as a QE in a medical device manufacturing company.
- Project management tracking and trending experience.
- Veeva Vault, Veeva Learning, Veeva QMS, Veeva PromoMats preferred.
- Deep understanding of FDA GMP principles and ISO 13485 requirements
- Experienced in the development and execution of validation activities for manufacturing and software.
- Experienced in building out elements of a QMS system, including creating quality plans, developing and releasing SOP’s, training and process mentoring.
- Experienced in the use of data analytics development tools such as Power BI or others.
- Firmly understands the best practices for driving effective corrective and preventive actions and can mentor others in that process.
- Six Sigma experience
- Lean manufacturing experience
- Advanced statistical data analysis skills
- Ability to manage multiple projects and tasks with ease
- Internal/External auditing experience preferred. .
- Ensures environmental consciousness and safe practices are exhibited in decisions
- Use of computer and telephone equipment and other related office accessories/devices to complete assignments
- May work extended hours during peak business cycles
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