Engineer (Quality Engineer Investigator)

Position Summary:

This position is to investigate and manage day to day Non Conforming Material-NCMR’s. When raw materials and/or product does not meet specification, the role of the investigator is to follow procedures that will help guide them in the development of writing  an investigation to determine root cause and possible corrective actions to the problem.

Responsibilities:

• Investigate and manage day to day Non Conforming Material-NCMR’s  related to raw materials and/or finish good in the manufacturing process. (This will encompass the majority of your time)
• Evaluate, develop, and improve manufacturing processes by studying product and manufacturing methods.
• Collaborate with Supply Chain, Reagents Operations Engineering, Incoming QC, Final QC, Manufacturing, Quality, and Purchasing to identify and lead material and/or finish good  related issues to ensure optimum manufacturing process in terms of keeping manufacturing moving.
• Manage materials related to quality issues in the area of Tape, Webbing, Tubing, and Card production. 
• Provide daily decisions on service, manufacturing, and engineering to ensure product quality.
• Participate in the development of long-term strategies for materials and process improvements.
• Conduct validations and feasibility studies to assess new technologies or process improvements in material or process design.
• Support CAPA’s with regard to  root cause analysis and fishbone activities related to material and/or manufacturing processes.
• Ensure all activities comply with Good Manufacturing Practice (GMP), ISO, and Quality System requirements.
• Ensure that all health, safety, and environmental requirements are fulfilled.
• Support the development of capital business cases for new material/process/equipment development projects.
• Help Resolve quality related issues on the manufacturing floor and/or incoming QC.
• Obtain and analyze data, as required, to ensure key metrics, such as, but not limited to OEE, MSP, and yield are achieved.

Studies and Experience:

• Bachlors Degree required in Scientific/Engineering Area: Such as Biology, Chemistry, Manufacturing/Mechanical Engineering is required.
• 3+ years of Non-Conforming investigation writing is preferred.
• 3+ years of experience working  in an FDA Regulated Environment is preferred.

Skills and Qualifications:

• Background working in a high volume manufacturing setting.
• Ability to collaborate professionally with all levels of management in a cross-functional team environment is required.
• Knowledge of FDA/ISO regulations and process validation is preferred.
• Strong Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required.
• Must have strong communication and interpersonal skills.
• Must have strong analytical and problem-solving skills.

Physical Requirements:

• Extensive standing, repetitive hand and arm motions, ability to climb steps.
• Lifting (up to 50Lbs) and moving containers of cartons, tubes, and printed materials.
• Must be able to push a wheeled cage that can weigh up to 600 lbs fully loaded.
• Operating within cool temperature and low humidity conditions within the production room.  Constant noise is common due to the operation of the air-dry chamber, taping and pouching equipment. 
• Excellent personal hygiene required. 
• Appropriate gowning requirements necessary for the production areas.  Gloves are required to handle the product. Hairnet, clean room gowns and/or lab coats are required. Safety glasses and hearing protection are required personal protective gear.