Senior Continuous Improvement Quality Engineer

4 weeks ago


Peachtree Corners, United States Cynet Systems Full time
Job Description

Responsibilities:
  • Reporting to the Sr. Manager, Continuous Improvement Quality Engineering, the Sr. Continuous Improvement Engineer is responsible for creating and supporting a quality culture by driving activities across the organization to manage continuous process/quality improvement programs that strongly align with company standards and customer needs while meeting all applicable Medical Device Regulations and Standards.
  • Candidates will lead CAPAs and collaborate with subject matter experts on various activities in addition to supporting other improvement initiatives.
  • Candidates will evolve existing processes/systems to ensure timely escalation identification of product quality & compliance issues within a closed loop quality management system.
  • Work to collect and analyze data, drive rigorous root cause analyses and facilitate cross-functional discussions to ensure we are seeing 'all the way around' issues for complete resolution.
  • Candidates will lead internal audits as necessary.
Skills, Experience, Education, And Training:
  • Minimum Bachelor's Degree in engineering or a related field.
  • Advanced degree (Master's in Engineering or a related field) preferred.
  • Minimum 8+ years of progressive hands-on experience; or equivalent combination of education and experience.
  • Strong interpersonal and communication skills.
  • Ability to scale and deliver presentations based on audience background.
  • Knowledge of Quality Systems Regulations (21 CFR 820), ISO 13485 and ISO 14971 preferred.
  • Knowledge and hand on experience with Process improvement tools and methodologies (Lean, Six Sigma). Green or Black Belt Certification in Lean or Six Sigma is preferred.
  • ASQ certification (CQE) is a plus.
  • Experience gathering/processing internal and external requirements.
  • Business Acumen - has demonstrated business knowledge and ability to display the linkage between projects and desired business results.
  • Proven ability to drive creative problem solving related to product and process issues.
  • The ability to collaborate effectively with product and/or process subject matter experts in a cross-functional team environment is required.
  • Technical aptitude is required to collect and analyze data for determining an improvement strategy.
  • Ability to navigate multiple projects with changing priorities. Ability to execute to project timelines. Project Management experience and certification preferred.
  • Strong analytical, problem-solving and RCA skills.
  • Proven track record of managing and successfully closing CAPAs on time and with objective effectivity.
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