- Owning and maintaining Complaint Handling, CAPA, and Document Control processes ensuring compliance with FDA regulations and ISO standards from clinical development through commercial launch.
- Leading post-market quality activities including complaint intake investigation trending signal detection assess MDR reportability field actions corrective actions as needed.
- Serving as a key Quality partner supporting pharmacovigilance clinical activities adverse event assessment safety documentation coordination internal stakeholders external safety vendors ensuring compliant safety reporting for combination products.
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We are looking for a Quality Engineer (Medical Devices) who will serve as the Quality representative and Design Controls lead on cross-functional teams developing complex electromechanical and robotic medical systems. · ...
Auburndale $80,000 - $145,000 (USD) per year1 week ago
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Job Title: · Quality Engineer (Medical Device)- · (USC/GC Only) · Pay Rate: · $65 to $70/hr · Duration: · 12 months · Location: · Newton, MA · We are looking for a Quality Engineer (Medical Devices). · Serve as the Quality representative and · Design Controls · lead on cross-func ...
Auburndale, MA $80,000 - $145,000 (USD) per year1 week ago
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The Senior Quality & Regulatory Engineer will serve as the primary U.S. quality lead for Class II spine medical devices, · ensuring regulatory compliance and seamless oversight of international manufacturing partners.Lead the U.S. Quality Management System ensuring alignment with ...
Watertown2 weeks ago
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Company Description · Cube Hub Inc. is a women-owned minority business enterprise specializing in talent management solutions. We provide managed services in diverse domains, including IT, Engineering, Business Professionals, Finance, Marketing, Life Sciences, and Creative Servic ...
Newton $80,000 - $145,000 (USD) per year1 week ago
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Job Details · Job Title: Sr. Design Quality Engineer · Location: Newton, MA · Shift: 9:00 AM – 5:00 PM · Duration: 11-Month Contract (with possible extension) · Required / Preferred Skills · Minimum 4-year degree in Engineering, Biomedical Engineering, or Life Sciences. · 7–10 y ...
Newton $80,000 - $145,000 (USD) per year6 days ago
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The job description includes the responsibilities of a Quality subject matter expert supporting the development of sterile single use medical devices with ownership of packaging and sterilization considerations to ensure compliance with applicable standards. The Quality engineer ...
Newton2 weeks ago
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We support medical device companies to be more efficient by providing resources, knowledge, and expertise.Our vision is to closely align clients' needs with the best resources available in the marketplace. · We take proactive action to create ongoing future improvement by identif ...
Waltham3 weeks ago
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The Senior Quality & Regulatory Engineer will serve as the primary U.S. quality lead for Class II spine medical devices, ensuring regulatory compliance and seamless oversight of international manufacturing partners. · ...
Watertown, MA2 weeks ago
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At Lumicell, we'll give you the opportunity to harness all that's within you by working in a mission driven start-up environment with high-performing employees, tackling some of the most important challenges in cancer surgery. We are working to revolutionize the way cancer surge ...
Waltham, Massachusetts, , United States1 week ago
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Support quality activities for sterile, single-use medical devices and packaging including risk management. · ...
Newton, MA $80,000 - $145,000 (USD) per year1 week ago
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The OPAL Mapping System is a 3D mapping and navigation system and an effective diagnostic tool for cardiac electrophysiology (EP) procedures. · ...
Waltham $45 - $55 (USD)3 weeks ago
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This role serves as the U.S.-based quality and regulatory lead ensuring full compliance with medical-device regulations while overseeing quality systems supplier performance and imported product controls. · ...
Weston2 weeks ago
- Work in company
Quality Engineer OR Test Engineer OR Quality Design Engineer
Only for registered members
We are currently looking for an ambitious Senior Design Quality Engineer (contractor) to join our client. We are a global technology leader in robotic-assisted vascular interventions.This is a role well suited to an ambitious professional, looking for the next step in their caree ...
Newton2 weeks ago
- Work in company
Quality Engineer OR Test Engineer OR Quality Design Engineer
Only for registered members
We are currently looking for an ambitious Senior Design Quality Engineer (contractor) to join our client. We believe the combination of endovascular robotics, image guidance and dedicated devices will change the way neurovascular procedures will be done in the future, enabling be ...
Newton, MA2 weeks ago
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+Job summary · The OPAL Mapping System is a 3D mapping and navigation system and is an effective diagnostic tool for cardiac electrophysiology (EP) procedures. +Design, develop and execute test cases to ensure the quality of the product by proving system functionality, verify bus ...
Waltham3 weeks ago
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This role leads Design Controls, risk management, and V&V quality oversight to ensure regulatory compliance and robust product realization across the lifecycle. · Serve as Quality representative and Design Controls lead on cross-functional teams. · Ensure compliance with FDA QSR ...
Auburndale2 weeks ago
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Job Title: Design Quality Engineer (Medical Device)-(USC/GC Only) · Pay Rate: $65 to $70/Hr · Duration: 12 months · Location: Newton, MA · We are looking for a Design Quality Engineer (Medical Device) to join our Endovascular Robotics development group. · New Product Development ...
Auburndale $90,000 - $155,000 (USD) per year5 days ago
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+This organization provides a wide range of diagnostic imaging and laboratory diagnostics... · Develop, document, and execute comprehensive test cases... · ...
Auburndale2 weeks ago
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We are seeking a Supplier Quality Engineer to join our growing Supplier Quality team. You will be part of a cross-functional team responsible for managing supplier qualification, risk mitigation, and quality performance. · ...
Waltham, MA1 month ago
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We are looking for a talented Staff Quality Manufacturing Engineer to support the Atlas program, helping to transform groundbreaking research prototypes into reliable, scalable systems for manufacturing and field deployment. · Lead the development of quality systems for Prototype ...
Waltham $101,545 - $139,625 (USD)3 weeks ago
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We are hiring Quality Engineers to support our rapid customer growth. Do you thrive on working on the edge? Do you want to transform an industry? · This job is for you if your true strength is the ability to prioritize and communicate effectively to get you through even the most ...
Waltham $84,000 - $109,000 (USD) Full time1 month ago
Senior Quality Engineer - Waltham - Lumicell
Description
Senior Quality Engineer
Lumicell is revolutionizing cancer surgery, starting with breast cancer. Our mission-driven start-up environment offers a unique opportunity to work alongside high-performing employees tackling some of the most important challenges in cancer surgery.
About the Role:
Requirements:
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Quality Engineer
Only for registered members Auburndale
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Quality Engineer
Only for registered members Auburndale, MA
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Quality Engineer
Only for registered members Watertown
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Quality Engineer
Only for registered members Newton
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Quality Engineer
Only for registered members Newton
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Quality Engineer
Only for registered members Newton
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Software Quality Engineer
Only for registered members Waltham
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Quality Engineer
Only for registered members Watertown, MA
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Senior Quality Engineer
Only for registered members Waltham, Massachusetts, , United States
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Quality Engineer
Only for registered members Newton, MA
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Software Quality Engineer
Only for registered members Waltham
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Quality Engineer
Only for registered members Weston
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Quality Engineer OR Test Engineer OR Quality Design Engineer
Only for registered members Newton
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Quality Engineer OR Test Engineer OR Quality Design Engineer
Only for registered members Newton, MA
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Engineer - Software Quality Engineer II
Only for registered members Waltham
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Design Quality Engineer
Only for registered members Auburndale
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Design Quality Engineer
Only for registered members Auburndale
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Quality Assurance Engineer
Only for registered members Auburndale
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Supplier Quality Engineer
Only for registered members Waltham, MA
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Staff Manufacturing Quality Engineer
Only for registered members Waltham
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Quality Assurance Engineer, Manufacturing
Full time Only for registered members Waltham