Job Description
About Paradromics
Paradromics is building an advanced brain computer interface (BCI) platform engineering neurotechnology solutions for unmet medical needs. A revolutionary leap beyond today’s research-grade BCI, our Connexus® BCI collects neural signals at an industry-leading, high-data rate and is designed for long-term therapeutic use. With the brain in direct communication with digital devices, we can leverage technology to transform how we treat conditions ranging from sensory and motor deficits to untreatable depression and pain management—allowing millions of people to live happier, healthier, and more enriching lives.
The Role
As a Quality Assurance Engineer, you support the implementation and maintenance of our Quality Management System and conduct general QE activities. You are responsible for enhancing the understanding of, and compliance with, medical device standards and regulations across the company.
This position is a hands-on Quality Affairs role that involves equipment and production control activities, as well as directly interfacing with engineering and production teams to optimize and document product design, processes, and controls. The role focuses on efficiency and compliance and demands a proactive approach and clear communication to support the company's growth and success.
The ideal candidate is a self-starter with a "can-do" attitude who is enthusiastic about working collaboratively and engaging in hands-on, detailed, quality work. This role is crucial in supporting the company's continued development and future success. It is based on-site in Austin, Texas and involves less than 5% travel.
Responsibilities
- Support production by collaborating to implement processes and improvements
- Ensure effective use of Design Controls, Verification & Validation (Design & Process), Operational Controls, and Document Controls by working closely with engineering and operations teams
- Effectively communicate Quality Assurance requirements and needs to cross-functional teams
- Support the maintenance and continuous improvement of the Paradromics’ Quality Management System
- Support the generation and maintenance of risk management files, specifications, and manufacturing processes supporting product development
- Investigate and resolve quality events such as Nonconformances, CAPAs, Complaints, and Audit findings
- Work with the team to ensure the maintenance of equipment calibration and qualification records
- Participate in the development, delivery, and administration of quality training programs
- Perform Document Controls activities including document review and assessment
- Maintain metrics for Management Reviews and KPIs to continually monitor the Quality System
Required Education
- Bachelor’s degree in an Engineering, Science, or technical field
Required Qualifications
- 3+ years’ experience, at least 1 year of medical device experience
- Working knowledge of medical device quality standards and regulations, including FDA QSR (21 CFR 820), ISO 13485, and ISO 14971
- Experience working with premarket/early phase devices (e.g., Investigational Device, Design and Development, Design Verification, etc.)
- Experience supporting production activities, including oversight of process validations (IQ/OQ/PQ)
- Experience conducting impact assessments and change control activities
- Experience creating procedural directions including work instructions and forms as needed
- Excellent attention to detail
- Able to develop creative solutions to complex problems that meet regulations and business needs
- Able to work effectively in a team environment with a diverse group of people
- Good written and oral communication skills
Preferred Qualifications
- Certification(s) in a Quality-related discipline (e.g., CQE, 6 Sigma, Lean, etc.)
- Knowledge and practical application of IEC 60601-1, IEC 62304, and IEC 62366 requirements
- Experience with eQMS and ERP software
- Experience developing active electronic devices (e.g. neuromodulation)
- Experience in microfabrication/electronics device manufacturing
- Experience working for a startup medical device company
- Experience supporting external audits (e.g., FDA, EU Notified Bodies, etc.)
- Able to read/interpret engineering drawings featuring GD&T and/or electrical schematics
Paradromics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.
Job Tags
Full time,