AESCULAP, INC. Quality Engineer, CAPA in St. Louis, Missouri

Summary: Experienced Quality professional with FDA Quality Systems Regulations (21 CFR Part 820), ISO 13485 and ISO 14971 experience. Responsible for executing and managing multiple CAPAs simultaneously. Proven expertise in problem solving and utilization of root cause analysis tools. Works with quality management and senior management to ensure CAPAs are adequately resourced and executed in a timely manner. Writes and implements standard operating procedures (SOP) which are necessary to ensure Quality compliance and the safety and performance of Aesculap distributed products. Works closely with other departments including but not limited to Operations, Complaint Handling, Marketing, Engineering, Supply Chain, and Customer Service to resolve quality related issues. Principal Duties Responsibilities: Maintains and manages multiple CAPAs simultaneously, and aggressively facilitates each assigned CAPA to a timely closure (completion of Effectiveness Checks). Ensures CAPAs are documented and stored per record management procedures. Coaches and mentors other employees on CAPA execution and methodology. Proven leader to lead cross functional teams for CAPA projects. Aids in preparation of monthly CAPA Review Meetings. Identifies, documents, and initiates CAPAs with the CAPA board. Works with CAPA team members on utilization of root cause analysis tools Writes and/or assists in writing new SOPs or revising existing SOPs as required. Assists in the implementation/training of those new or revised documents. Issues monthly reports to Quality management as requested. Active participation in External Audits, Management Reviews, and Internal Audits as requested. Must comply with applicable ISO and FDA regulations as stated in Quality Manual. Must embody the Company's Vision, Mission and Values. Other duties may be assigned by manager.Supervisory Responsibilities: NA Job Specifications: 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. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons. Education/Experience: BS in a Life Science or Engineering discipline is preferred with a minimum of 5 years Medical Device Industry or other regulated industry experience (i.e., Pharmaceutical, Aerospace, Automotive). ASQ certification(s) preferred (i.e., CQE, CQIA, CQM, CQA) Requires knowledge of FDA Quality System Regulation, ISO 13485, and ISO 14971. Requires understanding of problem solving and root cause analysis tools. Must have experience in the use of CAPA methodology. Microsoft Office (Word, Excel, Power Point). Must have ability to process, analyze and present data. Good oral and written skills required.Language and mathematical skills; reasoning ability: Reasoning Ability: Ability to define problems, collect date, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Mathematical Skills: Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. Language Skills: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present in