Post Market Engineer-Medical Device/Phamaceutical Industry

Category:

Engineering

Employment Type:

Contract

Reference:

BH-384989-1

Yoh has an immediate, 4- month contract
opportunity, as a Post Market Engineer, within the Medical Device Industry


to our client, Onsite
strongly preferred to report to from their office in Gainesville, FL


***This role is a W2 and is not STEM/OPT or H1B eligible***
***Local candidates will be considered before remote**

• $100-135/hr. max hourly rate
• 40 hours, Mon-Friday
• Medical Device or Pharmaceutical FDA regulated environment, Complaint Investigation & Engineering problem-solving techniques during complaint investigation activities

• Applies strong/solid foundation in Root cause analysis using structured methodologies (e.g., 5 Whys, Fishbone diagrams, Fault Tree Analysis)
• Performs complaint product analysis and testing per Exactech's procedures and requirements.
• Performs complaint root cause analysis and supports conclusions with objective evidence and sound rationale.
• Performs complaint risk analysis and complaint history reviews.
• Escalates complaint investigation findings, as appropriate and per Exactech's procedures and requirements.
• Documents all complaint investigation, coding, and escalation activities per Exactech's procedures and requirements.
• Coordinates the initiation of new complaints and regulatory reporting, as determined during investigation.
• Supports the completion of complaint activities in line with department metrics and key performance indicators.
• Knows and applies client Quality System requirements and any appropriate FDA and international standards.
• Assists and supports other elements of the complaint handling process as directed.

• Bachelor's Degree in an Engineering discipline from an accredited institution required.
• Must have an understanding of root cause and risk analysis as well as technical writing.
• Previous experience in the Medical Device or Pharmaceutical FDA regulated environment required; product complaint investigation and handling preferred.
• Experience with FDA/ISO quality management system regulations.
• Must have excellent communication (verbal & written) 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, and perform analyses with accuracy.
• Strong organisational and time management skills.
• Self-directed; capable of setting own priorities and working independently to meet established deadlines.
• Must have knowledge of various software packages including Microsoft Office applications.