Sr Operational Excellence Engineer

Job Title: Sr. Operational Excellence Engineer
Job Duration: 12 months Contract on W2
Job Location: Sunnyvale CA 94086 OR AtlantaGA 30092

Primary Function of Position:

The Sr. Operational Excellence (OpEx) Engineer will be responsible to support the Regulatory Affairs & Quality Assurance (RAQA) organization and some strategic business related programs to achive the annual improvement goals. Works collaboratively with RAQA teams to provide best practices guidance in identifying opportunities planning and executing initiatives to 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 leading Kaizen events process mapping 5s or other lean tools. Use Gemba to identify and implement improvements on the production floor.

Roles & Responsibilities:

Reporting to the Sr. Manager RAQA OpEx the Sr. OpEx 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 the organizations standards and customer needs while meeting all applicable Medical Device Regulations and Standards.
S/he may 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 crossfunctional discussions to ensure we are seeing all the way around issues for complete resolution.
S/he may lead internal audits as necessary.

Skills Experience Education & Training:

Minimum Bachelors Degree in engineering or a related field
Advanced degree (Masters in Engineering or a related field) preferred
Minimum 8 years of progressive handson 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 crossfunctional 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 problemsolving and RCA skills.
Ability to travel up to 10% of the time.