Talent.com
Quality Engineer

Quality Engineer

ActalentDoral, Florida, USA
30+ days ago
Salary
$36.00–$50.00 hourly
Job description

Description :

  • Manage companies customer returns and complaint activities, including investigations and international shipments. Maintain Quality System processes, procedures and records ensuring compliance to FDA and ISO requirements specific to these processes.
  • Facilitate, manage and maintain safety compliance to OSHA standards and regulations

oHelp establish written policies and work procedures that will create and maintain a safe workplace (OSHA)

oEnsure employees are properly trained on health and safety practices and regulatory standards (OSHA)

oComplete safety orientation with new hires to show the locations of safety equipment, evacuation routes, external meeting points, and potential hazards.

  • Responsible for preventative maintenance and calibration program, general upkeep of facilities, equipment monitoring, waste removal (e-waste, Biohazard and Chemical) and recycling.

    • oMaintain tracking maintenance / calibration schedules, and spare parts inventories as applicable.

  • Supervise resources and daily work operations related to product returns, complaint investigations and calibration / maintenance activities to meet department objectives by recruiting, selecting, orienting, training, assigning, scheduling, coaching counseling and disciplining employees; communicating job expectations, planning monitoring, appraising, and reviewing job contributions; planning and reviewing compensation actions; enforcing policies and procedures.
  • Responsible for writing, reviewing, and maintaining procedures per ISO 13485 and 21 CFR part 820 requirements.
  • Participate in Safety Committee meetings and help facilitate action items as applicable.
  • Other duties as required, including the management of audits and site visits by OSHA state, county, and city officials.

    • Skills & Qualifications :

  • Knowledge of FDA, ISO, OSHA and medical industry regulatory requirements is preferred.
  • 3+ years related quality assurance, quality system experience or an equivalent combination of experience and education. Medical device experience preferred.
  • Supervisory experience is preferred
  • Ability to process technical information using sound judgment and providing clear rationale when making decisions
  • Proficient in use of Microsoft Office
  • Good organizational, attention to detail and follow-through skills
  • Excellent verbal communication and customer interface skills