Senior Quality Engineer

About the Company

Our client is a medical device company that serves the global diabetes care wound care and drug delivery marketplaces. Their mission is to improve lives by making medical devices which contribute to improved diagnostics and therapy. With a 49 year heritage the client is proud to be one of the largest providers of lancets and lancing devices in the world. They desire to deploy business models that make their products accessible across the globe while providing an opportunity for growth and development to their employees all with the highest level of quality.

Headquartered in Atlanta GA the company manufactures and markets products and services to the industry s premier OEMs and retailers. They are an FDA registered company with the entire organization being committed to providing medical devices and services that meet and/or exceed patient regulatory and customer requirements through an effective Quality Management System. The company leverages their product intellectual property high volume manufacturing capabilities and global supply chain to deliver their products and services across the globe.

What Youll Be Doing in this Role

Plan and direct activities concerned with development application and maintenance of quality processes materials and products. Additionally responsible for investigating manufacturing and customer nonconformance determining root causes and corrective actions reviewing and approving protocols and final reports and developing product specifications and sampling plans.

Primary Responsibilities:

• Reviews and approves validation protocols and final reports for equipment product and processes.
  
• Resolution and continuous improvement for root causes analysis including Nonconformance Reports (NCR) and Compliance.
  
• Investigates manufacturing and customer nonconformances (complaints) through root cause analysis (RCA).
  
• Develops and implements corrective action necessary to resolve NCR/CAPA issues.
  
• Conducts effectivity checks for all root cause analysis CAPAs and document findings.
  
• Formulates responses to customer complaints.
  
• Facilitates improvement projects and teams.
  
• Interacts with customers and suppliers routinely to ensure that product quality is constantly maintained. Addresses all product quality issues for current products. Oversees and maintains all quality functions related to packaging and manufacturing.
  
• Participates in FDA inspections ISO audits and customer audits of the plant quality system.
  
• Performs supplier and internal audits generates audit reports and manages responses.
  
• Develops and initiates standards and methods for inspection testing and evaluation.
  
• Devises sampling procedures and designs and develops forms and instructions for recording evaluating and reporting quality and reliability data.
  
• Develops product specifications and sampling plans.
  
• Establishes program to evaluate precision and accuracy or production equipment and testing measurement and analytical equipment and facilities.
  
• Develops and implements methods and procedures for disposition and discrepant material and devises methods to assess cost and responsibility.
  
• Direct workers engaged in measuring and testing products and tabulating data concerning materials product or process quality and reliability.
  

Requirements

• Minimum of 8 years Quality Engineering related experience and/or training is required.
  
• Knowledge of QSR ISO 13485 CFR 820 and EN regulations.
  
• Knowledge of process improvement SPC and other statistical process methods.
  
• Knowledge of process and product validations.
  
• Experience in development of Measurement Systems Analysis GR&R and Test Methods.
  
• Supplier/Internal Audits
  
• Must be able to lift and carry up to 50 pounds.
  
• Must be able to push/pull max force of carts or pallets up to 25 pounds.
  

Preferred

• Experience in medical devices desired.
  
• Experience in Biological Evaluations.
  
• Experience in molding.
  
• CQE Certification
  
• CQA Certification
  

Benefits

• Insurance: Health/Dental/Vision/STD/LTD/Life
  
• Participation in the Company s 401(k) plan
  
• Participation in the Company s Paid Time Off Policy
  
• Holiday Pay 10 paid holidays