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Quality Engineer

Katalyst Healthcares & Life Sciences Green River, WY
  • Expired: over a month ago. Applications are no longer accepted.

Roles & Responsibilities:
  • Gather project requirement and understand the scope of each project.
  • Able to lead risk management activities including creation/update of Risk Management Plan, Hazard Analysis, Design FMEA, Product User Risk Analysis, Risk Benefit Analysis and Risk Management Report
  • Support Internal/external Audit. Able to record Audit observations, and closure of the same.
  • Understand and perform the product complaint analysis, Customer Quality procedures
  • Supports Quality, Manufacture, Service, and Marketing departments on product Quality issues.
  • Perform statistical analysis using statistical software like Minitab
  • Creating appropriate harm/hazard analysis/health hazard assessment for issues potentially impacting patient outcomes
  • Investigate, identify and implement corrective and or preventive actions to close design control CAPAs
  • Understanding company level Quality requirements and cascading it is project level. Assess design control procedure updates and determine product and business impact
  • Engaging with project teams to gather and incorporate feedback to improve design control
  • Understand/Prepare technical product documentation including design history files, drawings, bills of materials, test protocols and reports, engineering change orders (ECO), etc.
  • Work with manufacturing engineer/process engineer to understand process controls per Mfg process control plan.
  • Assess impact of validations on SOPs, FMEAs and Quality Control Plans
  • Change Management support
  • CAPA council support
Job Skills:
  • Continuous interaction with Engineering team for project activities.
  • Interprets regulations and gives appropriate opinions.
  • Understanding of SaMD requirements.
  • Ensures compliance with accepted domestic and international medical regulations and standards.
  • Maintains awareness of current regulation changes.
  • Participate on design review, author regulatory assessments for both new and modified products.
  • Participate in cross functional teams for development projects.
  • Demonstrated experience with formal problem-solving methodologies
  • Good Understanding of ISO 13485 Quality System Standards, FDA Quality System Regulations, ISO 14971, IEC 62366 and/or other international medical device standards
  • Advanced Technical Training in Quality Engineering principles, Risk Management, Process Excellence (Six Sigma) is preferred
  • ASQ Certification as a Quality Engineer is preferred
Experience:
  • Project management experience is required
  • Minimum (5 years) of Quality experience in medical device industry
  • ISO13485, FDA QSR, EU MDR/ MDD Requirements

Katalyst Healthcares & Life Sciences

Address

Green River, WY
82935 USA