Sr. Continuous Improvement Quality Eng

Primary Function of Position:

The Product and Process Quality Continuous Improvement Sr. QE will be responsible for Quality Engineering and strategic business related programs. Works collaboratively with other Operations Product Quality team to facilitate Engineering and Operations Management maximize efficiencies, achieve annual goals. Leads key Lean Quality projects such as reduction in rework, reduction in quality notifications, etc., and improves product quality processes attending Kaizen events, process mapping, 5s, or other lean tools. Is familiar with the Gemba process and product quality improvement on the production floor.

Roles & 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 ISI standards and customer needs while meeting all applicable Medical Device Regulations and Standards.

S/he will lead CAPAs and collaborate with subject matter experts on various activities in addition to supporting other improvement initiatives.

S/he 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.

S/he will lead internal audits as necessary.

Skills, Experience, Education, & 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.