Senior Continuous Improvement Quality Engineer

Amick Brown is seeking an experienced

• 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.

• 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.

• 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.
• Ability to travel up to 10% of the time.

• Health
• Vision
• Dental
• 401k with company match
• Paid time off
• Sick Leave
• Short-Term Disability
• Life Insurance
• Wellness & Discount Programs