Quality Engineer - Medical Device Manufacturing Job at CyberCoders
Quality Engineer - Medical Device Manufacturing
CyberCoders, Inc is proud to be an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.
Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.
Fast growing startup with the world's first non-invasive and continuous wearable technology that tracks human brain temperature through the Brain Thermal Tunnel. Our CSO discovered this tunnel which provides the first known method for thermal communication directly with the center of the brain. We are harnessing the unrivaled power of artificial intelligence and brain thermodynamics to develop services that will help manage, monitor and TREAT numerous health conditions such as Alzheimer's, Parkinson's, MS, Cancer, Influenza, Stroke Risk, Drug Efficacy, Sleep, Obesity, and so many more.
We offer ground-breaking research and development within the Medical Device Industry and are looking to expand our team with an experienced Design Quality Engineer in our new Miami Beach lab.
We offer ground-breaking research and development within the Medical Device Industry and are looking to expand our team with an experienced Design Quality Engineer in our new Miami Beach lab.
Top Reasons to Work with Us
1. Innovative and Ground-Breaking Technology
2. Fast-Growing MedTech Startup
2. Fast-Growing MedTech Startup
What You Will Be Doing
The Quality Engineer provides overall quality support for R&D department to improve overall product quality. As the Quality Engineer you will participate in quality improvement initiatives for risk management, internal/external qualifications and make recommendations to improve the design process based on findings from quality analysis. Collaboration across multiple disciplines is critical for the successful implementation of the corrective actions.
You will be responsible for performing critical verification/validation testing and aggregate performance qualification testing for 510k submissions. You will need to be well versed in ISO 13485, IEC 60601, and all proper protocols in line with Medical Device regulations.
You will be responsible for performing critical verification/validation testing and aggregate performance qualification testing for 510k submissions. You will need to be well versed in ISO 13485, IEC 60601, and all proper protocols in line with Medical Device regulations.
What You Need for this Position
Must have at least 3+ years of experience with the following:
" Identifying, developing, and implementing design/process controls to meet customer/specification requirements.
" Developing, modifying, applying, and maintaining quality standards, and generates protocols and reports.
" In-depth knowledge of pertinent FDA, ISO, CFR, etc. regulations and Companys Quality Assurance policies and shares this information as required.
" Developing and analyzing statistical data and specifications to establish acceptance criteria.
" Leading and /or supporting thorough investigations of quality issues (CAPAs, Non-Conformances, Audit Observations, etc.) and ensuring effective
corrective and / or preventive actions occur.
" Participating in cross-functional teams on process control, improvement, and optimization projects.
" Performing assessments of any given quality system to determine the effectiveness and dependability of such system.
" Ensuring all quality specifications are met for any given product or procedure and suggests methods to bring equipment and work procedures into compliance with quality control standards.
" Assisting in investigations for issues associated with raw material, components or finished goods.
" Verifying drawing and quality requirements.
Bachelor's Degree in Mechanical Engineering or related field is preferred.
This is an on-site role.
" Identifying, developing, and implementing design/process controls to meet customer/specification requirements.
" Developing, modifying, applying, and maintaining quality standards, and generates protocols and reports.
" In-depth knowledge of pertinent FDA, ISO, CFR, etc. regulations and Companys Quality Assurance policies and shares this information as required.
" Developing and analyzing statistical data and specifications to establish acceptance criteria.
" Leading and /or supporting thorough investigations of quality issues (CAPAs, Non-Conformances, Audit Observations, etc.) and ensuring effective
corrective and / or preventive actions occur.
" Participating in cross-functional teams on process control, improvement, and optimization projects.
" Performing assessments of any given quality system to determine the effectiveness and dependability of such system.
" Ensuring all quality specifications are met for any given product or procedure and suggests methods to bring equipment and work procedures into compliance with quality control standards.
" Assisting in investigations for issues associated with raw material, components or finished goods.
" Verifying drawing and quality requirements.
Bachelor's Degree in Mechanical Engineering or related field is preferred.
This is an on-site role.
What's In It for You
Compensation: $75k-95k DOE
- Health/Dental/Vision Insurance
- Life Insurance
- PTO / Sick / Vacation
- Potential for Options
So, if you are a Medical Device Design Quality Engineer with experience, please apply today!
Applicants must be authorized to work in the U.S.
CyberCoders, Inc is proud to be an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.
Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.
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