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Associate Product Surveillance Engineer in Naples, FL ,  at Arthrex

Date Posted: 6/18/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Naples, FL
  • Job Type:
    Engineering
  • Experience:
    Not Specified
  • Date Posted:
    6/18/2018

Job Description


Requisition ID:
41277
Title:
Associate Product Surveillance Engineer
Division:
Arthrex, Inc.
Location:
INC- Naples, FL

Main Objective:

Evaluate medical device products to determine if investigations are required, and perform investigations when required while following all applicable FDA 21 CFR 820 regulations and ISO 13485:2016 standards.

Essential Duties and Responsibilities:

  • Conduct complaint evaluations and investigations and ensure all findings are properly documented.
  • Evaluate and test returned product according to established specifications, drawings, and procedures.
  • Collect and record data in appropriate formats as part of continuous improvement.
  • Perform functional testing according to measurement and analysis procedures and or pass/fail criteria.
  • Confirm by objective evidence any non-conformances reported or observed with the product.
  • Work with various Engineering teams to facilitate complaint investigations based on technical complexity and determine non-conformance root cause(s).
  • Work with vendors to ensure vendor evaluations and investigations are timely and complete.
  • Analyze historical complaints and investigations for trending analysis.
  • Use risk analysis tools to evaluate product and system safety issues in accordance with procedure.
  • Work with Product Management and Engineering to create and maintain investigation methodologies.
  • Work with Product Improvement Quality Engineers to improve and maintain the complaint investigation process.
  • Identify and present quality issues with risk based prioritization.
  • Act as a liaison between Product Surveillance and Service Departments to resolve product return discrepancies.
  • Maintain Reliability Engineering laboratory equipment and ensures equipment is calibrated in accordance with procedure.
  • Proactively identify test equipment needs and submits recommendations to leadership.
  • Works with leadership to identify areas where efficiency and process improvements can be made.
  • Participate in FDA and ISO audits as required.

Incidental Duties:

The above statements describe the general nature and level of work being performed in this job.  They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Education and Experience:

Bachelor’s degree in Engineering or Engineering Technology discipline required.

Experience working with personnel of various skills sets and education levels preferred.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

Working knowledge of FDA 21 CFR 820, cGMP, and ISO13485:2016 preferred.

Knowledge of quality control, inspection, and electro-mechanical testing equipment preferred.

Excellent and proven interpersonal and communication skills preferred.

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of PC and MS Office programs, particularly MS Excel and MS Word required.

Familiarity with electrical and mechanical testing tools and methods is required.

Experience using SAP preferred.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.