Quality Specialist

Job Summary:

The Quality Specialist will obtain and maintain knowledge of current US and international regulations, guidance documents, and standards applicable to the Quality Management System. Further the Quality Specialist will ensure all current aspects of CurveBeam’s quality management system are being adhered to, utilized, and updated as required.

Essential Duties and Responsibilities:

• Knowledgeable on all applicable state, national, and international regulations and standards.
• Meeting Regulatory Requirements ISO13485, the EU (MDR), FDA and other MDSAP countries.
• Overseeing company processes for all aspects of the Quality Management System
• Documentation Control - Internal, Eternal and Records
• Audits - Internal and External Audits - Performs internal quality audits and effectiveness reviews (FDA’s QSR, ISO 13485, MDD/MDR, MDSAP).
• Suppliers - Conducts supplier evaluations and audits as applicable.
• Calibration - Ensure that equipment is calibrated and maintained in accordance with requirements, and that these activities are properly documented.
• Customer Complaints - Root cause analysis - CAPA determination
• Corrective and Preventative actions - Ensue CAPA’s initiated, as appropriate, and completed.
• Non-Conforming Products - Review non-conforming components/products to ensure proper disposition.
• Design controls - Monitoring and assuring Design team is working within quality requirements.
• Employee Training program
• Verification and Validation - Process Validation - (Ensuring all processes are effective and appropriate) - QMS software validation
• Any other QMS process required to meet applicable standards and regulations.
• Performs other duties and tasks as assigned by the Director of Quality and Regulatory Affairs

Education Requirements: 

• BS in an engineering, science, regulatory, or related discipline.

Experience:

• Experience in preparing Quality Management Systems for Medical devices.
• Experience in an FDA regulated Class II electrical medical device manufacturing environment preferred.

Computer Skills:

• Basic computer skills (operating system, file structure, network, etc.)
• Basic use of Microsoft products (Word, Excel, Outlook etc.)

Other Desirable Experiences:

• Experience with leading the efforts for PMA and 510K filings
• Experience with US Environment (EPA), Health and Safety (OSHA), Health Insurance Portability Accountability Act (HIPAA), General Data Protection Regulation (GDPR) regulations
• Experience as Management Representative
• Strong Interpersonal and Communicative Skills
• Strong Problem-Solving Skills
• Technically Inclined
• Knowledge of X-Rays and human physiology a plus
• Self-motivated, self-organized, and able to work with minimum supervision.

Job Type: Full-time

Benefits:

• 401(k)
• Flexible spending account
• Health insurance
• Paid time off

Schedule:

• 8 hour shift

Education:

• Bachelor's (Preferred)

Experience:

• Quality management: 1 year (Preferred)
• Process management: 1 year (Preferred)