Be involved in the medical device software design controls activities, in accordance with the FDA ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
Be involved in the medical device software design controls activities, in accordance with the FDA ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
Senior Quality Engineer
Chicago, IL · On-site +1
Be involved in the medical device software design controls activities, in accordance with the FDA ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
Senior Quality Engineer
Chicago, IL · On-site +1
Be involved in the medical device software design controls activities, in accordance with the FDA ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
Senior Quality Engineer
Redwood City, CA · On-site +1
Be involved in the medical device software design controls activities, in accordance with the FDA ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
Senior Quality Engineer
Redwood City, CA · On-site +1
Be involved in the medical device software design controls activities, in accordance with the FDA ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
Job Title: Quality Control Technician (Quality Engineer - Contract) Location: 100% Remote ... Experience in medical device or regulated laboratory environments This remote contract opportunity ...
Quick apply
Job Title: Quality Control Technician (Quality Engineer - Contract) Location: 100% Remote ... Experience in medical device or regulated laboratory environments This remote contract opportunity ...
Senior Quality Engineer II
Grand Rapids, MI · Remote
$90K - $122K/yr
Combined, we have more than a century of experience in the medical device space, and over two ... Ability to solve quality issues with remote suppliers * High attention to detail Why Join Genesis ...
Quick apply
Senior Quality Engineer II
Grand Rapids, MI · Remote
$90K - $122K/yr
Combined, we have more than a century of experience in the medical device space, and over two ... Ability to solve quality issues with remote suppliers * High attention to detail Why Join Genesis ...
Lead Quality Engineer
Chicago, IL · On-site +1
$120K - $165K/yr
Apply medical device quality system knowledge as part of quality leadership, including but not ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
Lead Quality Engineer
Chicago, IL · On-site +1
$120K - $165K/yr
Apply medical device quality system knowledge as part of quality leadership, including but not ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
$120K - $165K/yr
Apply medical device quality system knowledge as part of quality leadership, including but not ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
$120K - $165K/yr
Apply medical device quality system knowledge as part of quality leadership, including but not ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
Lead Quality Engineer
Redwood City, CA · On-site +1
$120K - $165K/yr
Apply medical device quality system knowledge as part of quality leadership, including but not ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
Lead Quality Engineer
Redwood City, CA · On-site +1
$120K - $165K/yr
Apply medical device quality system knowledge as part of quality leadership, including but not ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
Quality Engineer II
Neenah, WI · On-site +1
$90K - $110K/yr
Working knowledge of FDA requirements associated with medical device design and manufacturing. * Working knowledge of industrial quality engineering, six sigma techniques, and statistical analysis.
Quality Engineer II
Neenah, WI · On-site +1
$90K - $110K/yr
Working knowledge of FDA requirements associated with medical device design and manufacturing. * Working knowledge of industrial quality engineering, six sigma techniques, and statistical analysis.
Be Seen First
Medical Device Sales Representative
San Francisco, CA · Remote
$80K/yr
Remote (must live within territory - northern California, Oregon, or Washington) Hire Type ... Proven B2B sales experience (medical device experience preferred but not required) * Experience ...
Quick apply
Be Seen First
Medical Device Sales Representative
San Francisco, CA · Remote
$80K/yr
Remote (must live within territory - northern California, Oregon, or Washington) Hire Type ... Proven B2B sales experience (medical device experience preferred but not required) * Experience ...
Senior Software Quality Engineer
Neenah, WI · On-site +1
$110K - $140K/yr
Description We are hiring a Senior Software Quality Engineer The Senior Software Quality Engineer serves as a technical quality lead for software-enabled medical device systems, acting as a key ...
Senior Software Quality Engineer
Neenah, WI · On-site +1
$110K - $140K/yr
Description We are hiring a Senior Software Quality Engineer The Senior Software Quality Engineer serves as a technical quality lead for software-enabled medical device systems, acting as a key ...
MES Developer Plano, TX (preferred) or Remote Visa - Usc and Gc (Strong Communication) 1+ year contract A MES Developer to help with new development for a Fortune-500 medical device client's overall ...
MES Developer Plano, TX (preferred) or Remote Visa - Usc and Gc (Strong Communication) 1+ year contract A MES Developer to help with new development for a Fortune-500 medical device client's overall ...
Director, Quality Engineering
San Diego, CA · On-site +1
In-depth knowledge of medical device regulations and standards, including FDA 21 CFR Part 820, ISO ... Remote or field-based positions will have different workplace arrangements which will be indicated ...
Director, Quality Engineering
San Diego, CA · On-site +1
In-depth knowledge of medical device regulations and standards, including FDA 21 CFR Part 820, ISO ... Remote or field-based positions will have different workplace arrangements which will be indicated ...
Medical Device/Combination Product Engineer
Vernon Hills, IL · On-site +1
$60K - $75K/yr
Work closely with cross-functional teams, including Quality, Regulatory, Manufacturing, Human ... Northwest Chicago Suburbs or remote for the right candidate Employee Type * W2 Employee ...
Medical Device/Combination Product Engineer
Vernon Hills, IL · On-site +1
$60K - $75K/yr
Work closely with cross-functional teams, including Quality, Regulatory, Manufacturing, Human ... Northwest Chicago Suburbs or remote for the right candidate Employee Type * W2 Employee ...
Contract Remote QA Testing Engineer Randstad is partnering with an education firm that is looking for a contract remote QA testing engineer (manual and automated testing). This role is responsible ...
Contract Remote QA Testing Engineer Randstad is partnering with an education firm that is looking for a contract remote QA testing engineer (manual and automated testing). This role is responsible ...
UI/Human Factors Engineer 3 as 100% Remote
Sunnyvale, CA · Remote
$75/hr
Remote Duration: 10 Months Pay Rate: $65.00 - $75.00/- on W2 Kindly help us with your most updated ... quality engineering, design controls, risk management and medical device product development.
Quick apply
UI/Human Factors Engineer 3 as 100% Remote
Sunnyvale, CA · Remote
$75/hr
Remote Duration: 10 Months Pay Rate: $65.00 - $75.00/- on W2 Kindly help us with your most updated ... quality engineering, design controls, risk management and medical device product development.
Manager, Product Quality Clinician - Medical Device / Complaint Handling & Cardiovascular RN
San Francisco, CA · Remote
**This position offers the flexibility of being fully remote, but the selected candidate must be ... Provides medical/clinical guidance to complaint investigators and engineers related to event ...
Manager, Product Quality Clinician - Medical Device / Complaint Handling & Cardiovascular RN
San Francisco, CA · Remote
**This position offers the flexibility of being fully remote, but the selected candidate must be ... Provides medical/clinical guidance to complaint investigators and engineers related to event ...
Manager, Product Quality Clinician - Medical Device / Complaint Handling & Cardiovascular RN
Irvine, CA · Remote
**This position offers the flexibility of being fully remote, but the selected candidate must be ... Provides medical/clinical guidance to complaint investigators and engineers related to event ...
Manager, Product Quality Clinician - Medical Device / Complaint Handling & Cardiovascular RN
Irvine, CA · Remote
**This position offers the flexibility of being fully remote, but the selected candidate must be ... Provides medical/clinical guidance to complaint investigators and engineers related to event ...
Manager, Product Quality Clinician - Medical Device / Complaint Handling & Cardiovascular RN
Concord, NC · Remote
**This position offers the flexibility of being fully remote, but the selected candidate must be ... Provides medical/clinical guidance to complaint investigators and engineers related to event ...
Manager, Product Quality Clinician - Medical Device / Complaint Handling & Cardiovascular RN
Concord, NC · Remote
**This position offers the flexibility of being fully remote, but the selected candidate must be ... Provides medical/clinical guidance to complaint investigators and engineers related to event ...
Manager, Product Quality Clinician - Medical Device / Complaint Handling & Cardiovascular RN
California, MD · Remote
**This position offers the flexibility of being fully remote, but the selected candidate must be ... Provides medical/clinical guidance to complaint investigators and engineers related to event ...
Manager, Product Quality Clinician - Medical Device / Complaint Handling & Cardiovascular RN
California, MD · Remote
**This position offers the flexibility of being fully remote, but the selected candidate must be ... Provides medical/clinical guidance to complaint investigators and engineers related to event ...
Remote Quality Engineer Medical Device information
See salary details
$45K - $51.7K
1% of jobs
$51.7K - $58.5K
3% of jobs
$58.5K - $65.2K
7% of jobs
$65.2K - $71.9K
13% of jobs
$72.2K is the 25th percentile. Wages below this are outliers.
$71.9K - $78.6K
18% of jobs
The median wage is $81.4K / yr.
$78.6K - $85.4K
19% of jobs
$90.9K is the 75th percentile. Wages above this are outliers.
$85.4K - $92.1K
17% of jobs
$92.1K - $98.8K
9% of jobs
$98.8K - $105.5K
6% of jobs
$105.5K - $112.3K
4% of jobs
$112.3K - $119K
2% of jobs
$45K
$84K
$119K
How much do remote quality engineer medical device jobs pay per year?
What does a Remote Quality Engineer in the medical device industry do?
What are the key skills and qualifications needed to thrive as a Remote Quality Engineer in Medical Devices, and why are they important?
How do Remote Quality Engineers in the medical device industry effectively collaborate with cross-functional teams despite working off-site?
Job description
Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
PLEASE NOTE: This is a hybrid role requiring three days a week in the office. Candidates can be based out of our Chicago (Headquarters), New York, or Redwood City locations.
As a Senior Quality Engineer, you will:
Lead verification, validation and maintenance of host systems supporting Tempus Medical Device(s).
Lead risk assessments to determine testing strategies.
Be involved in the medical device software design controls activities, in accordance with the FDA Quality System Regulation, ISO 13485, GAMP5, Computer System Validation (CSV) standards and FDA guidance, other applicable regulatory requirements, as well as best practices in the software industry.
Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and computer systems against user, functional and regulatory requirements.
Responsibilities:
Support regulatory compliance of the host system operating with Tempus Medical Device(s).
Develop and maintain CSV policies, procedures, templates and work instructions.
Lead risk-based approach to host / computer system validation (HSV/CSV), SDLC and design controls activities.
Perform validation, re-validation and change controls of various AI, SaaS, and Tempus in-house developed software.
Author and review software validation deliverables, including Risk Assessments, Validation Plans, Requirements (URS), Validation Protocols (IQ, OQ, PQ), UAT (User Acceptance Test), and Validation Reports.
Collaborate with cross-functional teams in developing test-driven system/functional requirements, defining testing strategies and participating in test execution.
Support Change Management and Major Incidents (MI) processes, ensuring organizational compliance and continuous improvement.
Provide support to Quality and IT organizations in maintaining compliance to various policies, procedures and activities, including support during internal/external inspections and regulatory and customer audits.
Provide CSV guidance, coaching, mentorship, and training to test engineers within the team.
Qualifications
BA/B.S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines.
5+ years experience in FDA regulated domain (e.g. medical device, pharma, biotech)
3+ years experience in Computer System Validation (CSV).
Experience with industry standards and best practices for Medical device software and CSV such as Design Controls, GAMP 5, FDA 21 CFR Part 11, FDA (QSR) FDA 21 CFR 820.30, Medical device software (QMS) ISO 13485:2016, FDA 21 CFR 820, and Software life cycle processes (IEC 62304:2006).
Knowledge of quality system principles, practices, and standards for the life science industry.
Ability to deliver quality outputs without directions or under minimal supervision.
Chicago Pay Range: $90,000-$130,00
NYC/SF Pay Range: $100,000-$150,000
The expected salary range above is applicable if the role is performed from California and may vary for other locations (Colorado, Illinois, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.
Additionally,for remote roles open to individuals in unincorporated Los Angeles - including remote roles-Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.