About Us

• Develop and expedite quality programs with emphasis on conducting failure and hazard analysis, failure investigations and problem resolution. Examples: Complaints, CAPA’s, Production, Design Assurance.
• Provide QA Engineering support and expertise to Manufacturing, Engineering, Marketing and other company functions.
  • Review, edit, revise and approve all Labeling, Marketing Promotional materials, CAPAs, ECOs, new Procedures, new SOPs, Special Work Orders, Deviations, NCRs, Test Protocols, Test Reports, Validations, Tool files, FMEA’s.
  • Conduct failure and hazard analysis.
  • Problem Solving and failure investigations.
  • Lot testing, Device History Records approval and QA Lot Release.
  1. Develop and document Quality processes, procedures, and test methodologies.
  2. Maintain company compliance to FDA Quality System Regulations and ISO 13485 standards.
  3. Manage test protocol & report development for validations.
  4. Support new product development through DHF maintenance, FMEA, verification testing.
  5. Other duties as assigned.

• BS degree in engineering, a technical or scientific discipline; or equivalent experience.

Job Experience

• Minimum of 3-5 years in the Medical Device Industry.
• Minimum of 3 years in the Quality function working with QSR and ISO 13485.
• Experience with FDA and ISO 13485 inspections.

• Effective verbal and excellent technical writing skills.
• Ability to communicate and work effectively at multiple levels within the organization.
• Ability to organize and judge priorities.
• Excels at generating and maintaining organized and accurate records.
• PC skills, word processing, spreadsheet, database.