• Provide design control assurance and risk management support for the development of new products throughout the product lifecycle
• Provide quality engineering and process excellence support for existing products covering supply chain, production and post-production processes
• Organize and facilitate quality trending metrics and continuous improvement activities to improve process efficiency, product compliance and control

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• Provide quality assurance support throughout the product engineering and risk management process for the development of new products
• Define, interpret and classify critical quality characteristics for new products and processes
• Support supplier development and supply assurance for designated components and materials
• Produce and maintain raw material control records, manufacturing batch sheets and equipment cleaning forms at appropriate stages during the development and implementation of new products/technologies/processes
• Utilize best practices for experimental design, fundamentals of statistical process control, sampling rationale, and reliability assurance
• Participate in design and process evaluations including development of material and product specifications, test methods and risk analysis (e.g. DFMEA, PFMEA)
• Produce and maintain raw material control records, manufacturing batch sheets and equipment cleaning forms as required for existing products/technologies/processes
• Review documents and forms according to good documentation practices (GDP), e.g. SOP’s, batch records, lab data and reports, raw and intermediate material control records, etc. for accuracy, data integrity and completeness
• Provide technical assistance to carry out problem analysis/complaint investigation where necessary, e.g. QE, and CAPAs (OOS, Deviations, Complaint and NC investigation, etc.) and closeout
• Participate in cross-functional teams that impact product quality, time to market, increase efficiency, solve problems, generate cost savings, improve quality, and provide new concepts
• Participate in continuous improvement initiatives such as Lean and Six Sigma
• Track and trend department metrics, KPI and quality indicators
• Operate within the company’s standard operating procedures and review, maintain and create appropriate procedures for area of responsibility to ensure compliance with ISO 9001, cGMP, customer and Ortec requirements.
• Abide by company and OSHA safety standards set for work area
• Ensure engineering change management
• Conduct/Participate in quality audits (internal, customer and third party) as assigned
• Support product release through preparation and review of CoA/CoC and material labels

• Bachelor’s Degree in Sciences, Business or Engineering
• Knowledge of process, test and/or equipment validation preferred