This QE applies advanced Quality Engineering and scientific method techniques and principles to daily tasks and activities; applies relevant regulations, standards, and industry best practices to assignments; plans and conducts projects and activities with high technical responsibility, complexity and strategic input; Acts as a subject matter expert in all Quality Engineering and scientific matters; Develops and leads key strategic quality initiatives throughout the organization; receives periodic, strategic guidance from QE Management or Director in addition to other senior

functional leaders/stakeholders.

• Demonstrates high level of proficiency in applying established tools and methods to identify and realize new products or process introductions (ex. QMS, product related), and business improvements.
• Lead the use of, and/or develop innovative applications for risk management and risk mitigation tools and practices.
• Leads and/or contributes to root cause investigations of complex issues/problems using various problem-solving techniques and tools and assesses effectiveness of implemented corrective and preventive actions.
• Leads and/or contributes to the development of new detection systems by developing optimal methods for conducting equipment, process and product qualifications/validations.
• Develops process Quality control plans that are in accordance with product utilization and risk level.
• Develops, reviews, implements and/or maintains production and process controls systems using appropriate techniques and tools (ex. Statistical process controls, statistical inspection sampling)
• Ensures all levels of Design Controls per ISO 13485:2016 and QSR 21 CFR 820 are being utilized, in addition to other product regulatory requirements.
• Leads or participates in design/technical reviews as appropriate. Lead QE on product development projects.
• Interprets and implements standard and non-standard sampling plans.
• Act as a subject matter expert (SME) in all routine Quality areas (except for Quality Data Analysis related to company metrics)
• Partners with senior technical leaders (internal and external to the organization) to develop and implement innovative approaches for identifying technical opportunities .and quality and business improvements.

   

• Mentors others in various technical capabilities.

   

• Partners with senior technical leaders to develop innovative approaches for achieving technical and business improvements.

   

• Collaborate with other quality leaders to identify required Quality Engineering skills and competencies.

   

• Serves as the second to acting Quality Manager or Quality Director.

• Minimum 5 years professional experience in medical subassembly and finished device manufacturing.
• Technical degree in Mechanical or Biomedical Engineering Depth of knowledge in one or more clinical areas.
• Proficiency in Minitab or similar statistical analysis platform Knowledge of probability and statistics.
• Experience with transfer to production and/or sustained manufacturing of complex medical devices
• Able to work in an office environment and travel independently CQE and/or Six Sigma Green or Black belt
• BS degree: Physics, Optics, Mechanical, Chemical, Plastics, Engineering preferred
• Strong attention to detail and satisfactory organizational skills Able to self-manage project tasks

$86,000-$130,000