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Hybrid QA Post Market Engineer bei Exactech

Exactech · Gainesville, Vereinigte Staaten Von Amerika · Hybrid

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Performs complaint product analysis and root cause investigation in support of Exactech and regulatory requirements, product improvement, and issue escalation. 

Key Responsibilities

  • 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 the maintenance of orthopedic implants and instruments currently on the market as part of continuous improvement.
  • Supports CAPAs, HHEs, NCRs, and other quality processes, as needed.
  • Supports the completion of complaint activities in line with department metrics and key performance indicators.
  • Supports audits and audit requests for complaints.
  • Drafts investigation responses to customers, as requested.
  • Supports the drafting and revision of procedures, work instructions, forms, technical documents, and protocols.
  • Supports continuous improvement activities.
  • Assists in training complaint team members.
  • Know and applying Exactech’s Quality System and any appropriate FDA and international standards
  • Assist and support other employees, teams, and sales personnel as necessary. 

Skills Knowledge and Expertise

Education:
  • Bachelor’s Degree in an Engineering discipline from an accredited institution required; degree in Mechanical or Biomedical Engineering, or a Master’s Degree preferred.
 Experience:
  • Must have a basic understanding of theoretical technical principles in the following areas: 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.
Functional/Technical Knowledge, Skills and Abilities Required:
  • Must have excellent communication (verbal & written) and organizational skills.
  • Must have excellent interpersonal skills and must be able to work effectively in a team environment.
  • Must be detail-oriented and have the ability to consistently meet high standards of input accuracy, produce quality documents, compile data, and perform analyses with 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 have the ability to independently apply theoretical technical principles to product design.
  • Must have knowledge of various software packages including Microsoft Office applications.
  • To fully meet team responsibilities, the individual will develop additional knowledge and skills in anatomy and physiology, especially as related to the musculo-skeletal system, fundamentals of orthopedic surgery (major joints), mechanical test methods and procedures, quality and inspection methods, manufacturing processes and methods, FDA/ISO requirements, project management, orthopedic implants and the materials used in orthopedic implants and instruments.
Jetzt bewerben

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