Sr Quality Engineer (REMOTE)

Senior or Principal Quality Engineer (Based on Experience)

Industry: Implantable Medical Devices

Location REMOTE: Co HQ is South Florida: (Hybrid preferred); NOTE: open to fully remote out of state candidates

Intended Compensation Range: $95K-$105K base bonus (flexibility for higher base salary for qualified candidates)

Have a degree in electrical or mechanical engineering and proven experience in implantable medical device quality? This role is for you. Join a profitable, fast-growing medtech company transforming non-toxic pain management through wearable neuromodulation. As a Senior or Principal Quality Engineer, you'll lead cross-functional efforts across design control, product development, supplier quality, and manufacturing. This strategic role goes beyond traditional quality engineering-driving risk management and ensuring compliance with ISO 13485, FDA 21 CFR Part 820, and global standards. Help bring a breakthrough medical device from concept to commercialization. Apply now!

Key Responsibilities

• Lead implementation and maintenance of the Quality Management System (QMS)
• Support new product development and design control compliance (DHFs, V&V protocols, risk analysis)
• Drive manufacturing process validations, test method qualifications, and design changes
• Manage supplier quality: audits, SCARs, NCMR investigations, and performance monitoring
• Lead CAPA investigations, root cause analysis, and corrective/preventive actions
• Support regulatory submissions (FDA 510(k), global) and internal/external audits (FDA, Notified Body)
• Collaborate cross-functionally with Engineering, Operations, and Software teams
• Analyze quality data and KPIs to drive continuous improvement initiatives
• Act as Quality lead for equipment validations, change control, and document reviews
  
  

Qualifications

• BS in Electrical Engineering OR Mechanical Engineering (hard requirement)
• 8 years in medical device quality engineering (implantables)
• Strong knowledge of ISO 13485, FDA 21 CFR 820, ISO 14971, and design control principles
• Experience with risk management, FMEAs, and statistical analysis, V&V
• Skilled in CAPA, Lean/Six Sigma, and supplier quality management
• Excellent communication, documentation skills
  
  

Benefits

• $95-105k base Depends on Experience 5% bonus
• Huge Room for Growth!
• Bonus Opportunity
• Regular Company Functions
• Vacation/PTO
• Full Benefits: Medical, Dental, Vision
• Amazing Work Environment
• HUGE room for growth (lucrative startup)
• A team of sharp people on the same mission
• Must be authorized to work in the US without Sponsorship
• 401(k)
  
  

Email Your Resume In Word To

Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, but you may also:

chad.vasquez@cybercoders.com

• Please do NOT change the email subject line in any way. You must keep the JobID: linkedin : CV6-1879547 -- in the email subject line for your application to be considered.***
  
  

Chad Vasquez - Lead Recruiter

For this position, you must be currently authorized to work in the United States without the need for sponsorship for a non-immigrant visa.

This job was first posted by CyberCoders on 10/06/2025 and applications will be accepted on an ongoing basis until the position is filled or closed.

CyberCoders is proud to be an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity or expression, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, status as a crime victim, disability, protected veteran status, or any other characteristic protected by law. CyberCoders will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable state and local law, including but not limited to the Los Angeles County Fair Chance Ordinance, the San Francisco Fair Chance Ordinance, and the California Fair Chance Act. CyberCoders is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. Individuals needing special assistance or an accommodation while seeking employment can contact a member of our Human Resources team at Benefits@CyberCoders.com to make arrangements.