Senior Quality System CAPA Engineer Resume Concord, CA - Hire IT People

SUMMARY

7 years of direct experience with Product Nonconformance, CAPA Program Management and Investigation.
Sixteen years of Quality Assurance experience, with strong quality systems background in the medical device, diagnostic and bio - medical industries in the role of Sr. QA Engineer, Sr. QA project manager, Sr. QE and Sr. QA contractor/consultant with large, medium, and start-up companies.
Twelve years of experience in medical device product development, Design control, Quality assurance.
Ten years of QA experience in field failure, root cause analysis and reporting, with the emphasis on product improvement.
Experience developing design verification and design control plans, QA systems, test plans and management reports.
Fourteen years working with domestic and international medical device standards and requirements (ISO, MDD, FDA, GMP, QSR, IVD…).
Ability to perform and managed detailed risk management analysis tasks (FMEA, HA….), and help with Risk management plans, reporting, and their documentation, under ISO 13485, 14971, 21 CFR, QSR, GMP, MDD and others.
Two years maintaining internal and international standards and its gap analysis.
Have reviewed and influenced many product manuals, internal QA manuals, test procedures and reports, SOPs, DHF documents and management reports.

PROFESSIONAL EXPERIENCE

Confidential, Concord, CA

Senior Quality System CAPA Engineer

Responsibilities:

Quality Engineer, Investigator and team member for multiple CAPAs
Complaint Data Analysis and Reports
CAPA Tracker weekly Management reports and Charts
Provided Metrics to Management
Managed Database data entries and worked with corporate CAPA management
Introduced various CAPA tools to teams, guiding them towards identification of the real root cause/s and contributing factors.
Created various Excel spreadsheets
Helped teams to prepare for CRB (CAPA Review Board) reviews and approvals, for each phase.
Had Signature Authority as CAPA Quality Reviewer
Managed CRB meetings

Confidential

Senior Quality Engineer

Responsibilities:

Managed, Product, Process and Quality System nonconformance programs.
Managed all aspects of nonconformity investigation (Incoming and Manufacturing), product disposition, management reporting.
Reviewed Corrective Actions and made recommendations.
Appointed to the Supplier Quality team member to track and respond to specific to NCP (Nonconformance) issues.
Managed the NCP data logs; performed historical data searches, review and reports.
Generated the Quarterly Management Review Board’s NCP Reporting.
Reviewed Quality System Document Changes and made correction recommendations.

Confidential

CAPA Investigator- QC

Responsibilities:

Handled full investigation and root cause analysis of nonconformance and excursion reports, including manufacturing, customer complaints, and internal and external audit findings of both technical and non-technical nature.
Served as quality assurance liaison on the CAPA Review Board
Prepared Validation Review data for Preventive Maintenance reports.
Used Agile (Engineering change and Document control system), ETMS (Electronic Training Management System, and GQMS (Global Quality Management System) systems to document investigation results, perform database searches, generate management reports and get trained on various standards and internal SOPs.
Received certifications from Abbott Quality College for use of Quality tools including 6M, 5-Whys, Contradiction Matrix, Comparative Process mapping, Resolution planning, CAPA process, Root cause analysis, and Effectiveness planning and implementation.