- CAPA
- Medical device risk management
- Compliance effective oversight
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Quality Engineer
1 week ago
H3X Technologies Louisville, United StatesJob Description · Job DescriptionACTIVELY HIRING THIS ROLE BUT JUNIOR, SENIOR, AND MANAGEMENT LEVELS WILL BE CONSIDERED AS WELL. · JOB PURPOSE: · At H3X, we are building the most advanced electric motors in the world for sustainable aviation, marine, industrial, and defense appli ...
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Quality Engineer
1 day ago
H3X Technologies Louisville, United StatesJob Description · Job DescriptionACTIVELY HIRING THIS ROLE BUT JUNIOR, SENIOR, AND MANAGEMENT LEVELS WILL BE CONSIDERED AS WELL. · JOB PURPOSE: · At H3X, we are building the most advanced electric motors in the world for sustainable aviation, marine, industrial, and defense appli ...
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Senior Quality Engineer
1 week ago
Medtronic Lafayette, United StatesCareers that Change Lives · A career at Medtronic is like no other. We're purposeful. We're committed. And we're driven by our Mission to alleviate pain, restore health and extend life for millions of people. Help us engineer the extraordinary · Bring the next generation of lif ...
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Sr Quality Engineer
4 days ago
Alpha Consulting Lafayette, United StatesJob Title:Sr,Quality Engineer · Job ID: 12741 · Location: 250 Client Dr Bldg 1Lafayette Colorado 80026 · Duration: 07 Months Contract · Pay Range: $50-55/hr · Top 3 technical skills that you are required for the role: · CAPA · Medical device risk management · Compliance e ...
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Sr Quality Engineer
3 days ago
LanceSoft Lafayette, United StatesMust Have:CAPAMedical DeviceRisk ManagementRPM QualityNice to Have:10+ Years design experience in medical device industry, Class III experience helpful, but not required Kaizen Lean Six Sigma Certified Medical device industry experience Experience in Complaint Handling, Regulator ...
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Software Quality Engineers
1 week ago
Entegee Lafayette, United StatesJob Description · Job DescriptionSummary: Enhance software quality and ensure compliance with ISO 14971 for medical device software development through rigorous risk management, validation, and testing methodologies. · Job Responsibilities: · Develop, modify, apply, and maintain ...
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Sr. Software Quality Engineer
2 weeks ago
Primary Talent Partners Lafayette, United StatesPrimary Talent Partners has a 6 month contract opening for a Sr Software Quality Engineer with a Medical Device Client of ours in Lafayette CO. This role is onsite. · Pay Range: $55 to $65 per hour · Top 3 technical skills that are required for the role: · Risk management: exp ...
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Senior Software Quality Engineer
2 weeks ago
Infotree Global Solutions Lafayette, United StatesJob title: Sr Software Quality Engineer · Job location: Lafayette Colorado 80026 · Job Duration: 6 Months · Top 3 technical skills that are required for the role: · Risk management: experience in assessing and mitigating risks associated with SW development in medical devices fo ...
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Nexus Dynamics Commerce City, United StatesAbout Rail Power Systems GmbH: · We ensure that trains get off to a good start - because we are a leading company in the planning and construction of railway electrification and power supply systems. And we have been doing this for over 30 years. · What do we offer? · 30 days of ...
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Quality Engineer
1 week ago
Food Management Search Frederick, United StatesQuality Engineer · Job Description · The Role: · Our QE will work with the team to monitor and improve the quality of our processes and outputs. You will be responsible for designing quality standards, developing quality control systems, and leading cross-functional teams in ...
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Quality Engineer
3 weeks ago
Bridgeway Professionals Inc Frederick, United StatesOur QE will work with the team to monitor and improve the quality of our processes and outputs.You will be responsible for designing quality standards, developing quality control systems, and leading cross-functional teams in problem-solving, resulting in innovative, solid correc ...
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Quality Engineer
3 weeks ago
Lincoln Search Consultants Inc Frederick, United StatesQuality Engineer Job Description The Role: Our QE will work with the team to monitor and improve the quality of our processes and outputs. You will be responsible for designing quality standards, developing quality control systems, and leading cross-functional teams in problem-so ...
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Quality Engineer
3 weeks ago
Gables Search Group Frederick, United StatesQuality Engineer Job DescriptionThe Role: Our QE will work with the team to monitor and improve the quality of our processes and outputs.You will be responsible for designing quality standards, developing quality control systems, and leading cross-functional teams in problem-solv ...
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Quality Engineer
3 weeks ago
Odyssey Information Services Westminster, United StatesJob Description · Job Description · Location: · Onsite in Westminster, CO 80030 · Summary: · This position will utilize lean kaizen events to improve a product line or lines by training employees and using quality assurance process sampling systems, procedures and statistical ...
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Quality Engineer
3 weeks ago
Air Comm Westminster, United StatesQuality Engineer · Westminster, CO ) · Apply · Job Type · Full-time · Description · Description · The Quality Engineer will ensure the proper administration of quality assurance system(s) and ensure the continuous manufacture of superior value added products. Manage non-co ...
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Quality Engineer
3 weeks ago
Money Fit by DRS Westminster, United States: · Description · The Quality Engineer will ensure the proper administration of quality assurance system(s) and ensure the continuous manufacture of superior value added products. Manage non-conformance processes, drive continuous improvement efforts, and perform root-cause anal ...
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Quality Engineer
2 weeks ago
Job Juncture Longmont, United StatesJob Description · Quality Engineer · Job Description · The Role: · Our QE will work with the team to monitor and improve the quality of our processes and outputs. You will be responsible for designing quality standards, developing quality control systems, and leading cross-funct ...
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Quality Engineer
3 weeks ago
Affinity Executive Search Longmont, United StatesQuality Engineer · Job Description · The Role: · Our QE will work with the team to monitor and improve the quality of our processes and outputs. You will be responsible for designing quality standards, developing quality control systems, and leading cross-functional teams in p ...
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Quality Engineer
3 weeks ago
Energy Jobline ZR Longmont, United StatesJob Description · Quality Engineer · Job Description · The Role: · Our QE will work with the team to monitor and improve the quality of our processes and outputs. You will be responsible for designing quality standards, developing quality control systems, and leading cross-fu ...
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Quality Engineer
4 weeks ago
Danfoss LLC Longmont, United StatesJob Description · Danfoss is looking for an experienced, reliable, self-driven Quality Engineer to join our team at our Longmont, CO facility who is passionate and motivated towards delivering best quality and continual improvement. You will be responsible for Support and promot ...
Title: Medical Device Quality Engineer - Lafayette, United States - MasterCompliance LLC
Description
Job DescriptionJob DescriptionTitle:
Medical Device Quality Engineer
Location:
Lafayette, CO (Onsite)
Type:
W2 contract.
We have Mid-level and senior level openings for below positions.
6+ Years design experience in medical device industry, Class III experience helpful, but not required Kaizen Lean Six Sigma Certified Medical device industry experience Experience in Complaint Handling, Regulatory Reporting, FCA, FDA, and/or CAPA PMP Certification or other formal Project Management training and experience Program Management/Project Management.
Education Required:
Bachelor's Degree in Engineering, Science or technical field with 6+ years of work experience in Engineering and/or Quality.
Job description:
Responsibilities may include the following and other duties may be assigned.
A representative for the Released Product Management (RPM) Design Quality team on projects that address day-to-day quality issues of the market-released products.
Compliance effective oversight with the RPM activities per the applicable Standard Operating Procedures (SOP's) and External Standards as part of the process.
Risk analysis, including product risk assessment ownership, key stakeholder to various Failure Mode and Effects Analysis, and assessing specific product issues for impact to patient and/or user safety and product quality
Drawing and specification reviews
Verification and Validation testing and reporting
Product performance reviews
Test method validation
DHF audits
Mechanical drawing review and approval per ASTM-14.5Y.
Technical problem-solving compiles data and prepares reports on findings to identify trends proposes corrective action as needed.
Collaborates with RPM project cross-functional team to ensure quality standards are in place.
Specialize in RPM risk management, test method validation, and equipment
calibration/qualification/validation.
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