- Provide strategic direction for design change teams in terms of quality functions including design quality, manufacturing quality, process validation, supplier quality, post-market quality and risk management.
- Ensure proactive compliance to all applicable internal, domestic, and international regulations including US 21 CFR 820 (QSR), ISO 19471:2019 and ISO 13485:2016.
- Ensure compliant and complete product documentation, inclusive of DHFs, with particular focus on design controls, risk management and document controls.
- Lead extended Quality teams for design change projects.
- Review and approve design and development documentation including Design Development plans, Design Change plans, User Needs, Design Input and Design Output documents, Design Verification Protocols and Reports, Design Validation Protocols and Reports, and System Risk Assessment documentation.
- May review and approve engineering drawings, specifications, procedures, engineering changes, and manufacturing work instructions, etc.
- Assures that products subjected to design changes are successfully transferred into the supply chain including manufacturing and service environments.
- Participates in Design Reviews and develop, approve, and review associated documentation.
- Responsible for Design History File (DHF) completeness and maintenance.
- Utilize problem solving techniques ad take a broad perspective to identify innovative solutions.
- Interact frequently with other functional areas and operating entities which requires specialized depth and/or breadth of expertise
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Design Assurance Engineer
2 weeks ago
Compunnel Doral, United StatesTitle: Development Quality Engineer · Location: Miami FL 33196 · Duration: 12 months Contract · Description: · The Staff Development Quality Engineer supports new product development (instruments, reagents, consumables, and software) from a QA perspective. The primary role of th ...
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Quality Assurance Engineer
3 weeks ago
Sunrise Systems Doral, United StatesOur client, a leading medical devices company, is looking for a · Quality Assurance Engineer. · This is for an initial duration of · 7 months · and is located in · Miami, FL · Responsibilities: · strategic direction for design change teams in terms of quality functions incl ...
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Quality Assurance Engineer
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InterEx Group Doral, United StatesJob Description: · Scroll down for a complete overview of what this job will require Are you the right candidate for this opportunity · We are seeking a highly skilled and experienced Quality Engineer to join our team. The ideal candidate will have a minimum of 2 years of exper ...
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Design Assurance Engineer
3 weeks ago
Compunnel Doral, United StatesTitle: Development Quality Engineer · Location: Miami FL 33196 · Duration: 12 months Contract · Description: · The Staff Development Quality Engineer supports new product development (instruments, reagents, consumables, and software) from a QA perspective. The primary role of ...
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Quality Assurance Engineer
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Primary Talent Partners, Inc. Doral, United StatesPrimary Talent Partners has an exciting opportunity with our client in the Miami, FL area. This is a contract position with a duration of 7 months and possibility for extension or conversion. · No C2C candidates will be considered at this time. · Pay Range: $41/hr - $46/hr · S ...
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Quality Assurance Engineer I
3 weeks ago
Vivex Biomedical , Inc. Doral, United StatesJob purpose · The Quality Assurance Engineer develops, applies, revises, and maintains quality metrics to support areas of operations at Vivex Biologics, Inc. The role assists in the planning, development, implementation, communication, and maintenance of Vivex's quality manageme ...
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Software Quality Assurance Engineer
6 hours ago
Actalent Fort Lauderdale, United StatesJob Title: Software Quality Assurance Engineer · Job Description · Join our dynamic team as a Software Quality Assurance Engineer to work with innovative technologies crucial for product development. You will collaborate with both software and hardware teams, review user storie ...
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Supplier Quality Assurance Engineer
2 weeks ago
Trividia Health Fort Lauderdale, United States*Please note this position is Monday - Friday onsite located in Ft. Lauderdale, FL * · SUMMARY · Individual is responsible for the investigation, analysis and the resolution of supplier quality problems by conducting audits, analyzing defect trends and participating in continuo ...
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Project Superintendent
1 week ago
HR Exchange Doral, United StatesThe Superintendent is responsible for overseeing and coordinating all job site construction activities, working closely with the Project Manager to ensure the successful and timely completion of individual building projects. We are looking for a proactive team player with outstan ...
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Field Service Mechanic
2 weeks ago
Sudden Service Doral, United StatesBasic Purpose: · The accountability of this position is for the continuation of excellent customer relations between TMW and customers of new and used equipment by providing prompt and efficient service as authorized by customer and as assigned by the Service Supervisor. · Nature ...
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Supplier Quality Assurance Engineer
3 weeks ago
Trividia Health Fort Lauderdale, United States*Please note this position is Monday - Friday onsite located in Ft. Lauderdale, FL * · SUMMARY · Individual is responsible for the investigation, analysis and the resolution of supplier quality problems by conducting audits, analyzing defect trends and participating in continuo ...
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Supplier Quality Assurance Engineer
1 week ago
Trividia Health Fort Lauderdale, United States*Please note this position is Monday - Friday onsite located in Ft. Lauderdale, FL* · SUMMARY · Individual is responsible for the investigation, analysis and the resolution of supplier quality problems by conducting audits, analyzing defect trends and participating in continuou ...
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Ground Support Equipment
2 weeks ago
FEAM Doral, United StatesJob Type · Full-time · Description · Job Title: Ground Support Equipment (GSE) Regional Manager - MIA · Location: Miami, FL · ABOUT FEAM: · FEAM Aero is the MRO leader in Aircraft Line Maintenance Engineering in the U.S. FEAM leads the Line Maintenance industry with advance ...
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Ground Support Equipment
2 weeks ago
FEAM Technical Services, LLC Doral, United StatesJob Title: Ground Support Equipment (GSE) Regional Manager - MIALocation: Miami, FL · ABOUT FEAM:FEAM Aero is the MRO leader in Aircraft Line Maintenance Engineering in the U.S. FEAM leads the Line Maintenance industry with advanced aircraft repair capabilities, a wide line stat ...
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Senior Software Quality Assurance Engineer
1 week ago
Brave Health Miami, United StatesJob Description · Job DescriptionAbout Us: · Nearly 1 in 4 people in the U.S. get their healthcare coverage through Medicaid, but nearly two thirds of psychiatrists don't accept Medicaid. This gap has only grown larger over time, creating a clear opportunity for a model that deli ...
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HDR INC. Doral, United States· About Us · At HDR, we specialize in engineering, architecture, environmental and construction services. While we are most well-known for adding beauty and structure to communities through high-performance buildings and smart infrastructure, we provide much more than that. We c ...
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Senior Solutions Engineer
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MBR Partners Doral, United StatesJob Description · Job Description · Our client is looking for a Senior Solutions Engineer to promote our client's Next Generation service assurance solutions engineering to large-scale telecom operators in the Americas. · Company description · Our client is the leading expert ...
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Sr Construction Inspector
2 weeks ago
Colliers Engineering & Design Doral, United StatesOverview: · Colliers Engineering & Design is seeking Qualified Construction Inspectors to join our Construction Engineering & Inspection group in Florida. · Responsibilities: · To perform quality control construction observations for roadway and bridge construction, general site ...
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Manual QA Engineer
2 weeks ago
ATech Placement Doral, United StatesWe are looking for a Quality Assurance engineer who will focus on manual testing of the product. · Duties: · Design and create test scripts to address areas such as database impacts, software scenarios, regression testing, negative testing, error or bug retests, or usability in ...
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Network Engineer
2 days ago
TEKsystems Doral, United States: Network Engineer · active secret clearance required · As technical expert with complete latitude in day-to-day decision-making and focus on Network Design and Design Interface, provides system-level network solution engineering efforts associated with strategic planning of th ...
Senior Quality Assurance Engineer - Doral, United States - LeadStack Inc.
Description
Job title:
Quality Assurance Engineer- (Senior)
Location:
Miami FL 33196
Duration: 7 months
PR:
$35/hr - $46/hr on W2
Key Responsibilities: