Sr. Quality Engineer

Location: Alachua, FL

• Serves as a lead core team member of cross functional project teams whose responsibilities include coordinating deliverables for the improvement of processes across the manufacturing facility
• Supervises the Quality Assurance Engineering team including performance management, corrective action, hiring and selection, and allocation of engineering support as it relates to quality assurance initiatives
• Reviews quality Key Performance Indicator (KPI) data and actions to ensure continuous improvement in collaboration with various operations value streams
• Reviews validations and risk management activities to support regulatory submissions, sustaining activities, and product launches are on time and have a high level of customer and patient focus
• Leads and conducts problem solving through change management, nonconformance workflows, and continuous improvement or new product development initiatives
• Reviews and edits nonconformance investigation and disposition phases for team members and assists in the preparation and presentation of materials for quality initiatives
• Other duties as assigned

• Education: Bachelor’s degree in relevant technical discipline
• Experience: 6+ years of relevant medical device, pharmaceutical, or other regulated industry experience. Combination of advanced degree and experience may be considered.
• Certification: AATB or CTBS Certification, preferred;
  Lead Auditor Certification, preferred; ASQ – CQE, CBA, or CQA, preferred
• Skills: Excellent verbal and written communication;
  Technical writing;
  Problem solving methodologies;
  Microsoft Office Suite;
  Quality Management System software;
  Investigations;
  Statistical techniques
• Travel: N/A
• Physical Requirement: Move or lift objects up to 25 pounds;
  Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays;
  Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)
• Working Environment: Onsite:
  Office environment with assigned workstation;
  Remote positions only:
  Home office environment with minimum distractions