Ankleshwar, Gujarat, India
... Handling of Incident/OOS/OOT/Failure Investigations & Its Monthly Trends., non-conformance CAPA, CC, Deviations, market complaint, APQR, and Regulatory quires & its compliance . Responsible for compliance of instrument Qualification URS/IQ/OQ/PQ, ...
- 2025 Dec 21
Italy
... Led internal and external audits, management reviews, and developed corrective/preventive action (CAPA) plans to mitigate non-conformities. Directed risk assessments and supervised an international team of quality engineers. Served as Management ...
- 2025 Dec 20
Aiken, SC, 29801
... by the Nuclear Regulatory Commission (NRC) as a Subject Matter Expert (SME) in the field of Corrective Action Program (CAPA) & Performance Improvement (HPI) Recognized by INPO & IAEA as a Quality Assurance Program Subject Matter Expert Expertise ...
- 2025 Dec 18
Santa Clarita, CA
... Manage CAPA investigations and implementations across packaging/labeling, master data management, configuration management, and record retention processes. Partner with global teams to implement technical literature and product lifecycle management ...
- 2025 Dec 17
Santa Clara, CA, 95051
... [cont’d next page] CHRIS BROWN Page 2 • Participated in SCAR/CAPA/NCMR creation, review and resolution. • Followed rigorous QMS / FDA regulations. • Created and maintained manual MRP for majority of production parts, both direct and indirect. ...
- 2025 Dec 14
Minneapolis, MN, 55404
... • Initiated NCMR's and worked closely with Quality Engineers, as well as Manufacturing Engineers to resolve the issues and assist in carrying out CAPA's. • Assisted in improving the incoming goods inspection processes by implementing a skip lot ...
- 2025 Dec 14
Overland Park, KS
... Designed Power BI dashboards tracking safety metrics, CAPA closures, and regulatory timelines, increasing visibility for management across global units. Built Python scripts to preprocess regulatory data and feed it into Dataverse via REST APIs, ...
- 2025 Dec 11
Natick, MA
... • Expert with pre-approval of investigation, deviation, Root Cause Analysis (RCA), CAPA, OOS, OOT, and LE. • Over 30 years’ experience of EH&S and usage of PPE. • Lead continuous improvement on targeted business processes, using Lean Sigma, to ...
- 2025 Dec 10
Coimbatore, Tamil Nadu, India
... Process Excellence: Experienced in process validation (FAI, PFMEA, DOE) for New Product Introductions (NPI), supplier quality programs (IQC, OQC, SPC, RCA/CAPA), and driving Kaizen projects. Problem Solving & Continuous Improvement: Skilled in root ...
- 2025 Dec 10
Parsippany, NJ
... •Expertise for CAPA and non confirmance and prepared documented evidence for regulatory audits. Bristol-Myers Squibb,Summit West,NJ May 2019 to Jan 2024 Senior QA/Regulatory Affairs Compliance •Preparing and submitting regulatory filings, including ...
- 2025 Dec 09