Senior Continuous Improvement Quality Engineer - Peachtree Corners, United States - Cynet Systems

Cynet Systems Peachtree Corners, United States

3 weeks ago

Description

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.

#monsterit

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