Owens & Minor Quality Engineer in Arden, North Carolina
Utilizes engineering methodologies and other analytics to initiate, implement, and manage the quality management system that encompasses both products and processes within the facility.In addition, this position pursues improved operational effectiveness through the refinement of existing procedures or business processes to optimize validations, manufacturing processes, error proofing, and other quality system tools.
ESSENTIAL JOB FUNCTIONS:
1.Rigorous oversight of manufacturing processes to ensure all products are made with the highest possible quality within a lean manufacturing environment.
2.Provides key oversight to root cause analysis and effective CAPAs by both leading and ensuring appropriate training throughout the facility.
3.Conducts validation or qualification tests of new or existing equipment, processes or software in accordance with internal protocols or external standards.
4.Conducts sterilization validations in accordance with internal protocols and external standards.Supports activities related to the master sterilization plan.
5.Develops and manages aging studies for packaging which may include coordinating testing, analyzing data and documenting results.
6.Leverages various software programs such as Word, Excel, ERP system, Minitab and other necessary programs or project tools to manage and analyze data and complete work.
7.Provides analysis and interpretation of report data to other departments for data driven decision making.
8.May manage and improve the Master Validation Plan by designing protocols that involve proper sampling techniques, design of experiments, testing and statistical rationale.
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.Green/Black Belt Certification or Lean Manufacturing training a plus.
3.Three to five years of experience in a manufacturing environment preferred.
4.Solid base in quality engineering principles. Solid understanding of statistics, minitab and/or other statistical software experience.
5.Medical Device experience, knowledge of ISO 13485, and sterilization experience a plus.
KNOWLEDGE SKILLS & ABILITIES:
1.General PC knowledge with an ability to use statistical, spreadsheet, word processing and graphics presentation software.
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.
1.Ability to travel on a limited basis, up to 10%,