Description
Works with cross functional team to complete operations quality engineering activities (risk analysis, control plans, process validations) for process improvement, cost reduction, and new product development projects.Leads validations strategy and appropriately documents validation plans and results, including protocol and reports.
Leads production/manufacturing-related complaint investigations.
Conducts metrics reporting including statistical analysis.
Provides project direction, coaching, teaching, and mentoring for Quality Engineering and technical team personnel.
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Leads and implements various product and process improvement methodologies (e.g. Six Sigma and Lean Manufacturing).
Leads process control and monitoring of CTQ parameters and specifications.
BS degree in Engineering.
8+ years' experience in the Medical Device industry.
Engineering experience and demonstrated use of Quality tools/methodologies.
Experience implementing various product and process improvement methodologies (e.g. Six Sigma and Lean Manufacturing).
Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
Advanced computer skills, including statistical/data analysis and report writing skills.
Able to independently perform core team member role; able to manage and mentor technicians and engineers.
Advanced degree.
ASQ CQE or other certifications.