Senior Quality Assurance Engineer
ENSO has developed the first opioid-free, wearable device clinically proven to solve pain better than Vicodin. It works by delivering a patented electrical stimulation treatment that relaxes the muscles and calms the nerves wherever it is applied, and it's all controlled via an app on your smartphone.
We are looking for an experienced Senior Quality Assurance Engineer to join our agile, close-knit team and to help us become a leader in pain management.
We are looking for someone to help maintain regulatory compliance and manufacturing quality for current and future generations of our pain relief device https://ensorelief.com/product.
You will work to:
Assist in maintaining a Quality Management System for the company.
Work very closely with Regulatory, Clinical and R&D to meet goals.
Vendor Partners Oversight (VPs): Review and approve method
qualification, validation, and transfer protocols and reports. Work with
the VPs to resolve all issues relating from the review.
Review Certificate of Analysis and QC data for compliance to
procedures and specifications.
Review and approve product specifications and test methods.
Plan, conduct and document periodic GMP and other audits of VPs
Develop and maintain quality agreements
Regulatory and Inspection Support
Assist with European, FDA and other regulatory agency inspections
Serve as an SME for areas of responsibility during regulatory
Proposing quality improvements to Quality Systems to maintain
compliance and to ensure quality and adherence to GMPs.
Monthly Quality dashboard updates to Management
- Startup attitude
- 4+ years experience in class 2 medical devices
- Experience with manufacturing of class 2 medical devices
- Experience with process transfer (IQ/OQ/PQ) to initiate production
- A Bachelor’s Degree in Engineering, Chemistry, Biology, or Lifesciences, or equivalent education is required.
- 8+ years’ experience within QA in the medical device field.
- Self managing, takes the strategic direction and converts it into thetactical processes and procedures.
- Experience with wearable devices or sensors
- Experience designing test fixtures, automated tests, etc. for manufacturing