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
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