Quality Engineer

• Analyzes current "in house" raw material specifications to ensure appropriate features and limits are in place to support company manufacturing process.
• Evaluates company initiated raw material changes and coordinates appropriate testing and validation as required.
• Suggests and supports new methods or materials for continual improvement in the quality or efficiency of a product or process.
• Works to reduce costs in all areas of manufacturing by analyzing current equipment for process suitability and provides detailed plans for improvement.
• Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and procedures and other technical documents to insure compliance, efficient and safe procedures.
• Conducts Quality Investigations to identify root-cause of indentified production issues
• Works cross functionally to support real time production quality issues related to materials
• Authors material handling procedures for quarantined products based on quality issues

BASIC QUALIFICATIONS | EDUCATION:

• Bachelor's degree (BS) in Engineering or equivalent combination of education and experience.
• Minimum ten years engineering experience in a controlled manufacturing environment.
• Experience working in a GMP, FDA, ISO and USDA regulated environment.
• Knowledge of Database software; AutoCAD Design software; Development software; Internet software; Inventory software; Manufacturing software; Project Management software; Microsoft Excel software and Microsoft Word software.

PREFERRED QUALIFICATIONS :

• Experience with cGMP and ISO 13485 regulations and practices.
• Experience in design/build, automation, PLC programming, equipment troubleshooting.
• Experience with statistical analysis software (Minitab).

COMPETENCIES:

• Ability to be able to meet deadlines while working on multiple projects.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.