Quality Engineer - Post Market

Neocis • Miami, FL

23d • Onsite

About The Position

Neocis is an established start-up revolutionizing dentistry with Yomi, the first, and only FDA cleared robot for assisted dental surgery. The company collaborates closely with leading clinicians to develop innovative technologies that help advance patient care and improve quality of life. Based in Miami, Florida. Neocis is venture-backed with funding from several prominent investors.

The Role: The Quality Engineer - Post Market is mainly responsible for providing quality engineering support with particular focus on post-market activities such as complaint handling and management. Other activities may include working with manufacturing, R&D, Marketing, Sales, and other Quality functions to address post-market feedback. Also, this position will work with the QMS team to ensure post-market processes are appropriately defined, implemented, and maintained.

Requirements

• Bachelor’s Degree in Engineering, Science, or technical field with 5+ years of work experience in Engineering and/or Quality.
• Expert with complaint assessment and handling per 21 CFR 820.198 and other applicable standards.
• Proficient with compliance and documentation related to complaint assessment and handling
• Competent with appraisal of clinical data such as reading, analyzing and interpreting common scientific and technical journals and legal documents.
• Competent with active monitoring by applying and understanding statistical methodologies, as appropriate, for conformity assessment and investigative activities to resolve potential product and quality system opportunities for improvement and identify opportunities for continuous improvement
• Proficient with adverse event reporting per 21 CFR 803 and other applicable standards
• Competent with medical device recalls per 21 CFR 806 and other applicable standards
• Competent with Quality Management Systems (QMS), 21 CFR 820, ISO 13485 standards
• Competent with ISO 14971 and internal risk management process
• Proficient in understanding and documenting complex technical information
• Team player with competent communication skills and attention to detail
• Background and work experience in medical device industry
• Proficient with Project/team lead
• Competent with computer skills
• Competent with medical device software, and manufacturing
• Proficient at effectively presenting information to various internal and external customers.
• Proficient at problem solving and to make and suggest informed decisions
• Proficient with Root Cause Analysis tools

Nice To Haves

• Competent with quality assurance in a small start-up environment is a plus
• Lean Six Sigma tools knowledge is a plus

Responsibilities

• Complete training as applicable for Good Manufacturing Practices (GMP) related tasks.
• Follow all applicable Quality and Safety procedures
• Follow Good Documentation Practices (GDP)
• Develops, modifies, applies and maintains quality standards.
• Collaborates with all applicable functions to ensure quality standards are in place.
• Ensures that corrective measures meet acceptable standards and that documentation is compliant with requirements.
• Provides guidance and training to all applicable team members.
• Apply and understand statistical methodologies, as appropriate, for conformity assessment and investigative activities to resolve potential product and quality system opportunities for improvement.
• Lead and/or participate in corrective/preventive action teams in resolving production, customer and supplier issues (e.g., nonconformances, CAPA or CAPA activities, audit findings, complaint investigations, etc.).
• Support and participate in planned and unplanned internal, regulatory and/or notified body audits. Provide information that is timely, accurate and substantiated by objective evidence.
• Maintain company working areas and local environment in accordance with applicable general operating procedures.
• Maintain effective communications with supervisor and peers in daily activities.
• Ensures that all activities are carried out within regulations and laws governing business and quality operations
• Responsible for ensuring compliance with all local, national, international and company regulations, policies and procedures for Health, Safety and Environmental compliance
• Perform Internal and/or Supplier Audits
• Identify, analyze, and manage risk through product life cycle with use of FMEA and other risk management tools
• Responsible for reporting on post-market metrics
• Lead complaint board meetings
• Prepare, review, and oversee Health Hazard Evaluations (HHE)
• Responsible for executing, monitoring, and overseeing recall process
• Responsible for complaint handling and management (triage, assessment, investigation and closure)
• Prepare and submit Medical Device Reports (MDR) and/or other regulatory complaint reports as required
• Maintain an effective complaint handling reporting process
• Maintain an effective HHE and Recall process
• May perform regulatory support as required
• Other duties, as required

Benefits

• You’ll thrive in our innovative and collaborative environment
• Make an immediate impact on life-changing technology
• Avoid silos and “not my job” mentality in our smaller, fast paced, startup environment
• We offer sabbatical, parental leave and unlimited PTO policies
• Generous 401K plan with 4% company match
• Comprehensive benefits package that includes medical, dental and vision

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees