PLANT QA ENGINEER AN DEVICE

job title plant qa engineer an device
autoreqid 90111br
job family quality assurance
job category full-time
job classification experienced/established
division abbott nutrition supply chain
shift first
relocation assistance none
overview
at abbott, we provide the perspectives and experience necessary to translate science into real solutions for patients in over 130 markets worldwide.
skills/experience requirements knowledge of applicable regulatory standards and requirements for infant formula and nutritionals.project leader - quailty systems and act as the sme for the plnat capa and er procseses, as required.
discover a world of opportunities at abbott.national and international accolades,
significant work actiivties & conditions continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
percent of travel 0 - 20 %
country united states
state/province ohio
site location columbus, abbott is regarded as an employer of choice for our commitment to workplace excellence, oh
employer of choice
through numerous local.lead or supoprt the resolution and closure of exception reports in a timely manner.abbott\'s nearly 90, 000 employees are doing work that matters, today.through our diverse healthcare businesses, we connect people and potential in ways that no other company can.and to assure that key performance indications are achieved,
. continuously evaluate and improve the overall qa program to drvie process improvement opportunities, meet qa compliance objectives.
major responsibilities:
responsible for implementing and maintaining the effectiveness of the quailty system.lead and grow, our employees are given the tools to succeed, with challenging opportunities and work that makes a difference.fda - 21 cfr, part 820), cmdr - sor/dor 98-282, g. iso 13485, ce mark - 93/42/eec.
. identify new sources of quailty data or modify and enhance existing sources of quailty data for continuous improvement meetings.
. assist with the initiation and investigation of nonconformances and participate in the develpoment of correction activities and corrective actions, as required. we believe that diversity drives innovation,
eeo statement:
at abbott.
. write and/or review specifciations, engineering stuides, etc, valiadtion packages, chnage requests.g. suppliers or external regulatory bodies); demonstrated ability to manage several activities / projects at once, organize / prioritize work.the closure of compliance gaps, this position drives change that resluts in quality improevments, and measurable results, better relationships with customers.preferably in a science, engineering or life/physical sciences,
education requirements bachelor\'s degree.better relationships with customers, serialized and disposable medical devices, and measurable results in the areas of testing / evaluation, acceptance activities and the release of commodities, the closure of compliance gaps, proivde quality engineering and techincal support to drive change that results in quality improvements.
. work with engineering to proivde diretcion and leadreship in the develpoment of matreial or finsihed proudct specifications and reapir / assmebly processes and procdeures, as well as in the development and implemnetation of engineering studies and plant validation / verifciation activities.
expeirence in quality assuarnce: at lesat 5 yeras in a quality or manufatcuring engineering role or cloesly related position in a federally regulated industry.
thorough knowledge of manufacturing processes and quality assurance principles; understanding of the elements of the quality system regulation / iso 13485 / cmdr as well as plant, division and corporate quality/operational system requirements; results-driven; ability to successfully interact and communicate with all organizational levels internally and externally (e.
. coordinate and chair continuous improvement meetings.innovative thinkers who are passionate about the work they do, abbott employees are representative of the diversity of the patients we strive to serve every single day across the globe.this position is also challenged to work with the compliance manager to ensure compliance with federal regulations, international standards/directives, or other applicable governing bodies to ensure that an effective quality management system (qms) is maintained.
. chair the continuous improvement meetings and serve as a backup to the sr.
job description primary function / primary goals / objectives:
. failure to do so can result in regulatory vulnerability and regulatory action.
. work with the plant compliance manager to assess gaps (where they exist) and to continually evaluate internal plant policies and procedures to ensure that the plant\'s compliance activities meet the most current requirements (e.
given the demanding regulatory environment and the critical nature of medical device products, this position requires that the plant qe maintains a thorough knowledge of the manufacturing process, as well as the qms to sufficiently provide technical expertise, consultation and recommendations to ensure that the system is sustainable and compliant.
accountability / scope / budget:
this position reports directly to the plant quality assurance manager and is challenged to effectively provide direction, support and leadership to the plant from a quality engineering and technical stand point. ensure that the data sources are actionable and that they can readily identify trends that aid in decision making, planning and resolution at the plant.to ensure product quality is maintained. perform complaint investigations, and to monitor qa final acceptance activities,
. demonstrate leadership and work closely with cross-functional personnel to lead or support failure investigations.use quality tools to improve and assure quality.