- Reviewing design and development paperwork and records for compliance to internal procedures and regulations
- Ensuring accurate justification of statistical analysis and hypothesis testing
- Reviewing technical reports as well as documents for Design History Files
- Participating in device risk management activities including UFMEA, DFMEA, PFMEA
- Aiding in establishing statistical controls in development and transfer to manufacturing processes
- Verifying data integrity, electronic data storage and data sheet validations
- Reviewing and coordinating with QA Validation for all test method and design validations
- Reviewing activities related to Design Verification and Design Transfer of Medical Devices
- Ensuring work product meets regulations
- Supporting scientific, complaint, and test failure investigations
- Performing data trend analysis, participating in Phase Reviews, writing Quality Procedures, performing data/statistical analysis
- You have knowledge of the combination device development process
- You have experience with device risk management activities
- You have a quality mind-set
- Quality Engineer: 2+ years
- Sr. Quality Engineer: 5+ years
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Quality Engineer
2 weeks ago
Staff Management | SMX New Albany, United StatesStaff Management | SMX is currently in search of a Quality Engineer for our client located in New Albany, IN. This is a direct hire position with benefits. Send over your resume to the RPS Recruiter at so that we can get you started · Perks & Benefits · Weekly paychecks · Direct ...
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Quality Engineer II
6 hours ago
TEL Albany, United StatesLet's search for your next career at TEL. Use the form below to search our current opportunities and then apply. Please consider joining our Talent Community so that we may continue to engage with you.Job DescriptionQuality Engineer 2Let's search for your next career at TEL. Use ...
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Manufacturing Quality Engineer
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Tempur Sealy Albany, United StatesTempur Sealy is committed to improving the sleep of more people, every night, all around the world. As a leading designer, manufacturer, distributor, and retailer of bedding products worldwide, we know how crucial a good night of sleep is to overall health and wellness. Utilizing ...
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Quality Engineer I
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Quality Engineer
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Manufacturing Quality Engineer
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Senior Quality Engineer
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Bechtel New Albany, United StatesRequisition ID: 276292 · Relocation Authorized: National - Family · Telework Type: Full-Time Office/Project · Work Location: New Albany, OH · Extraordinary teams building inspiring projects. · Since 1898, we have helped customers complete more than 25,000 projects in 160 coun ...
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Process Quality Engineer
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Senior Quality Engineer
2 days ago
Naval Nuclear Laboratory Niskayuna, United StatesAbout Us · Working at the Naval Nuclear Laboratory we foster pride in belonging to an organization whose culture is made up of these core values: Trust, Empowerment, and Collaboration. Our company encourages diversity and inclusion in all its forms while ensuring the safety and r ...
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Senior Quality Engineer
3 days ago
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Product Quality Engineer
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Sr. Design Quality Engineer
1 week ago
Regeneron Pharmaceuticals East Greenbush, United StatesWe are currently looking to fill a Medical Device Quality Engineer position. This position will provide Quality Assurance oversight and ensure compliance in the support of combination device development life cycles. · In this role, a typical day might include the following: · R ...
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Quality Engineer
2 weeks ago
Eaton Niskayuna, United StatesEaton's IS AER MSD division is currently seeking a Quality Engineer. · The expected annual salary range for this role is $ $ a year. · Please note the salary information shown above is a general guideline only. Salaries are based upon candidate skills, experience, and qualifica ...
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Senior Quality Engineer
6 hours ago
Naval Nuclear Laboratory Schenectady, United StatesAbout Us · Working at the Naval Nuclear Laboratory we foster pride in belonging to an organization whose culture is made up of these core values: Trust, Empowerment, and Collaboration. Our company encourages diversity and inclusion in all its forms while ensuring the safety and ...
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Senior Quality Engineer
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Senior Quality Engineer
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Senior Quality Engineer
1 day ago
Naval Nuclear Laboratory Niskayuna, United States Full timeAbout Us · Working at the Naval Nuclear Laboratory we foster pride in belonging to an organization whose culture is made up of these core values: Trust, Empowerment, and Collaboration. Our company encourages diversity and inclusion in all its forms while ensuring the safety and r ...
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Commissioning Engineer/Technician
1 week ago
SilverWorks Albany, United StatesYour tasks · Commissioning of new plastic processing plants and servicing of existing plants · Inspection of assembly quality, identification of errors; performance of technical functional tests · Mechanical and process commissioning of ZSK machines and complete systems · Impleme ...
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Quality Engineer
4 weeks ago
NESCO Inc Schenectady, United StatesWell-established corporation in the Capital Region is looking for a talented engineering professional to join its Quality team. Due to continued growth this industry leader is in search of a Quality Engineer to help support its daily operations and long-term projects. Our client ...
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Quality Engineer
3 weeks ago
NESCO Inc Schenectady, United StatesWell-established corporation in the Capital Region is looking for a talented engineering professional to join its Quality team. Due to continued growth this industry leader is in search of a Quality Engineer to help support its daily operations and long-term projects. Our client ...
Sr. Design Quality Engineer - Albany, United States - Regeneron Pharmaceuticals, Inc
Description
We are currently looking to fill a Medical Device Quality Engineer position. This position will provide Quality Assurance oversight and ensure compliance in the support of combination device development life cycles.
In this role, a typical day might include the following:
This role might be for you if:
To be considered for this role you must hold a Bachelor's degree in an Engineering subject area and the following amount of work experience in combination device or medical device industry for each level:
Level is determined based on qualifications relevant to the role.
#REGNQA