Title: QA Engineer I
Location:- Ontario, CA
Duration:- 5 Months (Possibly Extend)
Experience: 0-3 years professional experience.
Education: Bachelor's Degree or equivalent. Certifications if applicable.
Train internal personnel in QA program requirements.
Prepare monthly CAPA status reports.
Participate in customer and regulatory agency audits.
b) Maintains, enforces, and manages a compliant and effective CAPA Process for the activities in scope, as well as for effective and lean structures and documents for Q&R processes at all levels including CAPA compliance to regulations and standards ensured through proactive support and facilitation of the CAPA activities with individual CAPA owners
c) Managing site CAPA program and leading CAPA Review Board meetings.
d) Establishes the Philips CAPA Management System and manages its deployment including IQ-OQ-PQ Validation for web-based designed tool for the CAPA system. Work on validation test protocols, conversion/migration of data, mapped configuration requirements mapped to corresponding regulation requirements as applicable for 21 CFR Part 11 and 820
e) Ensures proper CAPA planning and schedule meets the requirements of internal policies and external regulations.
f) Leads/participates in the maintenance of the CAPA documents and matrices for tracking trending and reporting.
g) Ensures the addition and management of any local QMS documents in line with the evolution of the CAPA.
• Solid Analytical skills - demonstrated ability to trouble-shoot complex process/system issues.
• Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.
• Strong computer skills, including MS Word (advanced user), Excel, Visio, and related MS Office applications.
• Proven analytical capabilities
• Excellent communication, organizational and project management skills
• Effective written and oral communications skills and computer skills required
• Network oriented and able to interact with different business functions and can work within numerous systems
• Work cooperatively in a team environment
• Experience with TrackWise, SAP, Agile, SharePoint & Salesforce (Preferred)