Owens & Minor Quality Engineer in Toano, Virginia
The Quality Engineer uses their personal experience and judgment applying learned engineering methodologies and other analytics to initiate, implement, and manage the master validation plan within the facility.The Engineer will have responsibility for improving operational effectiveness through the refinement of existing procedures or business processes to optimize validations.The Quality Engineer will be a key resource for new product and machine validations providing subject matter expertise.
ESSENTIAL JOB FUNCTIONS:
1.Creates, manages and improves the Master Validation Plan;designs protocols that utilize proper sampling techniques, strong design of experiments and tests and will provide statistical rationale.
2.Conducts validation or qualification tests on new or existing equipment, processes or software in accordance with internal protocols or external standards.
3.Conducts sterilization validations in accordance with internal protocols and external standards.Supports activities related to the master sterilization plan.
4.Develops and manages aging studies for packaging which may include coordinating testing, analyzing data and documenting results.
5.Leverages various software programs such as Word, Excel, SAP, Minitab and other necessary programs or project tools to manage and analyze data and complete work.
6.Provides analysis and interpretation of report data including the use of systems.
SUPPLEMENTAL JOB FUNCTIONS:
1.Performs additional duties as directed.
EDUCATION & EXPERIENCE REQUIRED:
1.Bachelor's degree (B.S.) in Engineering or other technical degree from a four-year college or university is required.
2.Four to six years of experience in the Quality field is required.
3.Three to five years of experience in a manufacturing environment preferred.
4.Green/Black Belt Certification or Lean Manufacturing training preferred.
5.Medical Device experience, knowledge of ISO 13485, sterilization, and Minitab experience a preferred.
KNOWLEDGE SKILLS & ABILITIES:
1.General PC knowledge with an ability to use statistical, spreadsheet, word processing and graphics presentation software.SAP knowledge a plus.
2.Strong written and verbal communication skills with an ability to translate technical information to non-technical users.Must have the ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations.
3.Strong organization and planning skills.Aptitude with an interest to lead teams and/or individuals with strategic planning and thinking.
4.Strong analytical capabilities with demonstrated skill in evaluating reports, identifying issues, noting trends, and reporting to management.Must be able to define problems, collect data, establish facts and draw valid conclusions.
5.Proven ability to learn new technical tools quickly.
EQUIPMENT, TOOLS & WORK AIDS
2.MS Office Suite
WORKING CONDITIONS AND ENVIRONMENTAL HAZARDS
1.Inside working conditions.
2.No environmental hazards indicated for this role.
1. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling.
2. Repetitive mtions: Making substantial movements (motions) of the wrists, hands, and/or fingers.
3. Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
4. Visual Acuity: Closely viewing in order to perform activities such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; inspection involving small defects, small parts and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.