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Quality Engineer
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Lumicity Lowell, United StatesPlease apply or send your resume to · The Quality Engineer is responsible for overseeing the quality assurance of medical devices, from initial design through manufacturing and post-market surveillance. This role ensures that all products are manufactured in compliance with ISO ...
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Site Quality Engineering Manager
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Quality Engineer
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Quality Engineer
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Pace Industries Chelmsford, United StatesStart here, end here. There is a reason why we have so many employees with 20+ years with the company-Pace offers careers. Join us in becoming the premier die casting manufacturer and engineering solutions supplier worldwide. · Summary: · The Manufacturing Quality Engineer will ...
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Quality Engineer
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Quality Engineer
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Lockheed Martin Corporation Chelmsford, United StatesJob DescriptionLockheed Martin Missiles and Fire Control (LMMFC) Chelmsford, MA is seeking a motivated and driven Quality Engineer to support our manufacturing operations. As a recognized designer, developer and manufacturer of precision engagement aerospace and defense systems f ...
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Quality Engineer
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Lockheed Martin Corporation Chelmsford, United StatesJob DescriptionLockheed Martin Missiles and Fire Control (LMMFC) Chelmsford, MA is seeking a motivated and driven Quality Engineer to support our manufacturing operations. As a recognized designer, developer and manufacturer of precision engagement aerospace and defense systems f ...
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Quality Engineer
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Quality engineer
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Randstad North Billerica, United Statesjob summary: Our client north of Boston is looking for a Quality Engineer to join their growing team This is a great opportunity for someone who is looking for a team oriented environment. Our client is very focused on working together to complete projects using cross collaborati ...
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Quality Engineer
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Lockheed Martin Chelmsford, United States· Description:Lockheed Martin Missiles and Fire Control (LMMFC) Chelmsford, MA is seeking a motivated and driven Quality Engineer to support our manufacturing operations. · As a recognized designer, developer and manufacturer of precision engagement aerospace and defense system ...
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quality engineer
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Randstad North Billerica, United Statesquality engineer. · + north billerica , massachusetts · + posted 1 day ago · **job details** · summary · + $70,000 - $85,000 per year · + permanent · + bachelor degree · + category computer and mathematical occupations · + reference1050753 · job details · job summary: · Our clien ...
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Quality Engineer
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Brooks Automation Chelmsford, United States Full timeDescription · The Supplier Quality Engineer is responsible for the overall supplier quality of specific suppliers, contract manufacturers and material commodities within Brooks. This position spans both technical responsibilities and supplier quality management with a focus on m ...
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Quality Engineer
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Randstad North America, Inc. North Billerica, United StatesOur client north of Boston is looking for a Quality Engineer to join their growing team This is a great opportunity for someone who is looking for a team oriented environment. Our client is very focused on working together to complete projects using Quality Engineer, Engineer, Te ...
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quality engineer
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Randstad North Billerica, United Statesquality engineer. · + north billerica , massachusetts · + posted today · **job details** · summary · + $70,000 - $85,000 per year · + permanent · + bachelor degree · + category computer and mathematical occupations · + reference1050753 · job details · job summary: · Our client no ...
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Quality Assurance Engineer
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Spectrum Dynamics Manchester, United StatesAbout Voith Group · The Voith Group is a globally operating technology company. With its broad portfolio of systems, products, services, and digital applications, Voith sets standards in the markets of energy, paper, raw materials, and transport & automotive. Founded in 1867, Voi ...
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Quality Engineer
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Randstad USA Billerica, United StatesJob Summary · Our client north of Boston is looking for a Quality Engineer to join their growing team This is a great opportunity for someone who is looking for a team oriented environment. Our client is very focused on working together to complete projects using cross collaborat ...
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Manufacturing Quality Engineer
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Peoplelink Staffing Solutions Chelmsford, United StatesThis location is a finishing facility (paint shop). Our casted parts move to this location for sandblasting, chromating, powder coating, painting, silk screening, pad printing, etc.. Among other duties, this QE will be tasked with troubleshooting finishing product, processes, non ...
Quality Engineer - Lowell, United States - Lumicity
Description
Please apply or send your resume to
The Quality Engineer is responsible for overseeing the quality assurance of medical devices, from initial design through manufacturing and post-market surveillance. This role ensures that all products are manufactured in compliance with ISO 13485, FDA, and other regulatory standards.
**Essential Duties and Responsibilities:**
**Quality System Management:**
Maintain and improve the Quality Management System (QMS) in accordance with ISO 13485 and FDA regulations.
Participate in internal and external audits, including preparing necessary documentation and follow-up on corrective actions.
**Validation and Verification:**
Design and execute validation protocols for new products and processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Ensure all manufacturing processes, equipment, and materials meet pre-set quality standards.
**Risk Management:**
Conduct risk analysis and management throughout the product lifecycle in accordance with ISO
Prepare and maintain Risk Management Files (RMF) for all products.
**Product Quality Assurance:**
Perform root cause analysis on product failures and implement corrective and preventive actions (CAPA).
Review and approve product testing methods and final product releases.
**Supplier Quality Management:**
Work with suppliers to establish quality requirements for materials, components, and sub-assemblies.
Conduct supplier audits and performance evaluations to ensure compliance with quality standards.
**Documentation and Reporting:**
Develop and maintain comprehensive documentation for quality assurance processes and procedures.
Generate quality reports for management review, including trend analysis and quality performance metrics.
**Training and Leadership:**
Train and support production staff on quality assurance standards and practices.
Lead cross-functional teams to address and resolve quality issues.
**Qualifications:**
Bachelors degree in Engineering, Quality, or a related field.
3+ years of experience in quality engineering within the medical device industry.
Strong understanding of FDA, ISO 13485, and other regulatory standards.
Proficiency in statistical analysis software and Microsoft Office Suite.
Excellent communication and interpersonal skills.
Strong analytical and problem-solving abilities.