Sr. Quality Engineer Job in Tipp City, Ohio US
Sr. Quality Engineer
**This position will be located in Tipp City, OH**
The Sr. Quality Engineer with a focus on aseptic manufacturing, is involved in all aspects of the manufacturing operation from assessing equipment needs and cost justifications, to documenting installation, qualification, and ongoing validation of equipment and processes. The Sr. Quality Engineer is also expected to assist in the identification and resolution of quality related issues.
I. Essential Duties and Responsibilities include the following. Other duties may be assigned.
The primary objectives of the Sr. Quality Engineer are:
• Review RCE’s to assure adequate funding to address GMP and potential product hazards.
• Contribute to development of appropriate process designs and validation protocols.
• Assist in execution of validation protocols.
• Support initial start-up production after engineering changes and/ or after producing new products.
• Perform product assurance reviews; identify key quality issues and assure their resolution.
• Provide Quality Assurance input to the change control program.
• Incorporate Division Quality Assurance standards into working manufacturing procedures.
• Assist in problem identification and resolution on all Quality Assurance projects.
Supervisory Responsibilities No direct reports.
II. Competencies
• Set vision and strategy: Communicate desired future. Identify the organization, processes and actions required to deliver it.
• Build our organization and inspire our people: Assemble and develop a skilled team. Inspire them to follow your ethical example.
• Know the business: Use a broad knowledge of Abbott’s businesses to respond to opportunities and risks.
• Drive for results: Establish high standards. Deliver the plan. Accelerate our growth.
• Make difficult decisions: Make the right decisions at the right time for the right reasons.
• Encourage open exchange of ideas and knowledge sharing: Listen well. Reward creativity and collaboration. Ensure everyone’s voice is heard.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Three years of relevant experience in Quality Assurance, Manufacturing, or Engineering. Experience and demonstrated competency in aseptic process validation preferred.
Language Skills High language skills required. Must effectively communicate with all plant manufacturing groups, plant management, Division Quality Assurance and outside regulatory agencies. Must have the ability to read, analyze and interpret complex documents.
Mathematical Skills High math skills required. Must be able to apply basic math concepts such as percentages, ratios and proportions to practical situations. Will use statistical concepts to evaluate product and determine batch disposition.
Reasoning Ability Position has authority to stop production and isolate product due to inferior quality. These decisions require high reasoning ability and must be made quickly to minimize cost and reduce risk.
Computer Skills Basic computer skills required. Must be able to develop and interpret graphs and spreadsheets. Must be familiar with all plant Quality Systems and Manufacturing computer systems.
CERTIFICATION REQUIREMENTS:
The A.S.Q. Certified Quality Engineering Certificate may substitute for part of the experience requirement.
Knowledge of Low Acid Food regulations, Infant Formula regulations, kosher laws, corporate policies, Division policies, plant procedures and other governmental regulations affecting the manufacturing and distribution of products produced at the plant.
Position will be graded 15/16 based on candidate's skills/experience level.
