Quality Engineer

Company: BIO FILM INC
Location: Vista
Posted on: June 16, 2022

Job Description:

Description:
The Quality Engineer (QE) works with the internal manufacturing engineers, supply chain and contract manufacturers to continuously improve performance of key system components (refine life cycle, reduce scrap, improve/repair processes) by implementing process controls and developing quality control plans. Responsible for the overall Quality, Risk, and Performance Management of suppliers and contract manufacturers. The QE tracks data, identifies improvement projects, and manages cross functional implementation to improve performance in Production and Supplier Quality. The QE has high upstream focus to limit cost and time investment maximizing Product Quality.

• PRODUCTION QUALITY, INCLUDING MONITORING AND CONTINUOUS IMPROVEMENT BY IMPLEMENTING & DEVELOPING QUALITY CONTROL PLANS, PROCESS CONTROLS AND UTILIZING APPROPRIATE QUALITY TOOLS.
• PERFORMANCE MANAGEMENT OF SUPPLIERS AND CONTRACT MANUFACTURERS, INCLUDING LEADING SUPPLIER AUDITS.
• DRIVING EFFECTIVE MANUFACTURING EQUIPMENT QUALIFICATIONS, PROCESS CAPABILITY EVALUATIONS AND PROCESS VALIDATIONS, INCLUDING COLLABORATING WITH THE MANUFACTURING ENGINEERS IN PROTOCOL GENERATION, REVIEW AND EXECUTION.
• ADMINISTRATION OF THE RISK MANAGEMENT PROGRAM, INCLUDING DEVELOPING PLANS, PHLS AND FMEAS.
• LEAD IN ROOT CAUSE INVESTIGATIONS AND DRIVING EFFECTIVE CORRECTIVE AND PREVENTATIVE ACTIONS.
  
  Requirements:
  QUALIFICATIONS AND EDUCATION REQUIREMENTS:

• BS IN ENGINEERING, CHEMISTRY, BIOLOGY, BIOTECH, CHEMICAL ENG, OR OTHER SCIENCE RELATED FIELD
• 3+ YEARS OF EXPERIENCE IN A SUPPLIER OR PRODUCTION QUALITY ENGINEERING CAPACITY.
• EXPERIENCE WORKING IN A REGULATED ENVIRONMENT WITH A STRONG KNOWLEDGE OF MEDICAL DEVICE FDA 21 CFR 820/ISO 13485:2016 REQUIREMENTS.
• WORKING KNOWLEDGE OF QUALITY SYSTEMS AND QUALITY RELATED TOOLS, SUCH AS FMEA, SPC, CPK, AQP, DOE.DESIRED EXPERIENCE:
  • PRIOR SUPPLIER AND INTERNAL AUDITING EXPERIENCE.
  • KNOWLEDGE OF 21 CFR 210/211 REGULATIONS.
  • PROCESS VALIDATION AND IQ/OQ/PQ EXPERIENCE.
  • AQL/STATISTICAL SAMPLING EXPERIENCE.
  • DESIGN CONTROL EXPERIENCE.
  • DESIGN V&V EXPERIENCE.
  • ASQ CERTIFICATION, CQE, CSQP, AND/OR CQA OR LEAD AUDITOR CERTIFICATION.
  • KNOWLEDGE OF ISO 14971.
  • PRACTICE IDENTIFYING, MITIGATING, AND RESOLVING RISKS (PHL, FMEA, FTA).
  • LEAN SIX SIGMA TRAINING.
  • KNOWLEDGE OF STATISTICAL SOFTWARE (MINITAB, JMP).
  • SCAR, CAPA, NCMR, AND CUSTOMER COMPLAINT INVESTIGATION AND ROOT CAUSE ANALYSIS EXPERIENCE (FISHBONE, 5 WHYS).
  • EXPERIENCE WITH PACKAGING SUPPLIERS AND CONTRACT MANUFACTURERS.
  • PROJECT MANAGEMENT SKILLS.PI178507834

Keywords: BIO FILM INC, Vista , Quality Engineer, Other , Vista, California