James Birkett Email & Phone Number

California, United States

California, United States

South San Francisco, California, Us

Danville, California, Us

• Managed Corrective and Preventive Actions (CAPAs) from initiation and root cause investigation through corrective action, verification and closure.• Managed Nonconforming Material Reports (NCMRs) from initiation and root cause investigation through disposition and closure.• Authored Health Hazard Evaluations (HHEs) to assess risk associated with nonconformities.• Managed Customer Complaints from initiation and investigation through closure.•Implemented and closed deviations for manufacturing changes.• Implemented corrective measures for internal and external audit findings.• Initiated and reviewed document changed orders for various quality system documents.• Performed post market surveillance research and authored post market surveillance reports.• Developed Manufacturing Process Instructions (MPIs) and LHRs for various manufacturing processes.• Reviewed Lot History Records (LHRs) for subassemblies and completed finished goods lot release.• Generated quality system metrics for management review.• Participated in the development, review, and approval of equipment qualification and process validation protocols and reports (IQ, OQ & PQ).• Authored design verification protocols and reports.• Reviewed and updated risk management documentation (hazard analyses, FMEAs, reports).• Reviewed and updated design documentation (trace matrices, product requirements, V&V protocols/reports).• Helped with preparation of Notified Body audits and assisted in auditing various qualify system areas.• Audits and implements improvements to Design History File (DHF) phases.

Danville, California, Us

San Diego, Ca, Us