Exactech

QA Post-Market Engineer

Exactech

full-time

Posted on:

Origin:  • 🇺🇸 United States • Florida

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Job Level

Mid-LevelSenior

About the role

  • Performs complaint product analysis and root cause investigation in support of Exactech and regulatory requirements, product improvement, and issue escalation.
  • Applies sound engineering problem-solving techniques during complaint investigation activities.
  • Performs complaint product analysis and testing per Exactech's procedures and requirements.
  • Performs complaint root cause analysis.
  • Performs complaint risk analysis and complaint history reviews.
  • Escalates complaint investigation findings, as appropriate and per Exactech's procedures and requirements.
  • Collaborates with cross-functional engineering teams to ensure thorough investigations and appropriate escalations.
  • Documents all complaint investigation and escalation activities per Exactech's procedures and requirements.
  • Provides design, engineering, and analysis support to other engineers and designers in maintenance of orthopedic implants and instruments as part of continuous improvement.
  • Supports CAPAs, HHEs, NCRs, and other quality processes, as needed.
  • Supports completion of complaint activities in line with department metrics and KPIs.
  • Supports audits and audit requests for complaints.
  • Drafts investigation responses to customers, as requested.
  • Supports drafting and revision of procedures, work instructions, forms, technical documents, and protocols.
  • Supports continuous improvement activities and assists in training complaint team members.
  • Know and apply Exactech’s Quality System and appropriate FDA and international standards.
  • Assist and support other employees, teams, and sales personnel as necessary.

Requirements

  • Bachelor’s Degree in an Engineering discipline from an accredited institution required; degree in Mechanical or Biomedical Engineering, or a Master’s Degree preferred.
  • Must have a basic understanding of theoretical technical principles: mechanical drafting, geometrical dimensioning and tolerancing, computer aided design, engineering statics and dynamics, mechanics of materials, mechanical engineering design, root cause and risk analysis, and technical writing.
  • Previous experience in the Medical Device or Pharmaceutical FDA regulated environment preferred.
  • Experience with FDA/ISO quality management system regulations preferred.
  • Must have excellent communication (verbal & written) and organizational skills.
  • Must have excellent interpersonal skills and ability to work effectively in a team environment.
  • Must be detail-oriented with high standards of input accuracy, document quality, and data/analysis accuracy.
  • Strong organizational and time management skills.
  • Self-directed; capable of setting own priorities and working independently to meet established deadlines.
  • Must be creative and able to independently apply theoretical technical principles to product design.
  • Must have knowledge of various software packages including Microsoft Office applications.
  • Will develop additional knowledge in anatomy and physiology (musculo-skeletal system), fundamentals of orthopedic surgery, mechanical test methods and procedures, quality and inspection methods, manufacturing processes and methods, FDA/ISO requirements, project management, orthopedic implants and materials used in implants and instruments.