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Process Quality Engineer
Ref No.: 18-14495
Location: Pomona, California
Intake form attached.

Responsibilities:
• Leading Corrective and Preventative Action (CAPA) program, leading cross functional teams in root cause analysis of failures.
• Lead, perform and document detailed Root Cause Analysis for CAPAs, complaints, quality issues and unplanned deviations.
• Analyze all manufacturing processes steps using process maps, value stream maps, process flow diagrams and suggest changes/additions to improve product quality, regulatory compliance and manufacturing efficiency.
• Lead and perform process and quality system audits, including document review to proactively make suggestions for process improvements and tighter controls.
• Create and maintain Risk Management File documents such as PFMEAs that identify Hazard Analysis Critical Control Points (HACCP) and are compliant with the requirements of ISO 14971:2012.
• Work closely with Manufacturing, Quality Control, Quality Assurance and Applications Support management to prevent non-conformities and provide solutions to complex issues.
• Review and approve Change Orders for process and equipment validations, manufacturing, inspection, in-process quality, equipment and testing process related changes.
• Support multiple projects, balancing priorities and resources to meet project and management expectations.
• Other duties as assigned.

Education and Experience Requirements:
• BS/BA in field of Engineering or Science such as Chemistry, Microbiology, Biology and Biochemistry.
• Minimum of 8 years of Quality Engineering, Supervisory or QMS Auditing experience in a manufacturing environment with IVD Medical Devices, Pharmaceuticals or Medical Devices.
• Extensive hands on CAPA System and manufacturing process improvement experience.
• Project Leadership experience is highly desired.
• Lean Six Sigma (Black or Green Belt), Certified Quality Engineer, Certified Quality Auditor desired
• Experienced in root cause investigation and tools

Other Requirements:
• Knowledge of FDA QSRs, ISO 13485:2016, ISO 14971:2012 standards and HACCP, GMP, GLP and GDP requirements.
• Ability to support and lead CAPAs and other projects with minimal supervision.
• Strong leadership skills, interpersonal skills and ability to work as a team player.
• Goal oriented, learns quickly, works in a collaborative manner with other departments.
• Good writing and verbal communication skills.
• Knowledge of computers and software programs including Word, Excel, Access, Visio, MS Project, PowerPoint and Agile.