San Diego, CA
... Was able to identify an issue that, although out of the scope of the protocol, had the possibility of causing a CAPA in the future. Lead for pinch clamp consolidation of parts for cost down. Worked with Corporate Marketing on sample scheduling and ...
- Jul 08
Chicago, IL
... rating Failure Analysis of controls and components support Field Return analysis and corrective action to prevent PPAP, CAPA, APQP, PFMEA, SIX SIGMA BLACK Consultant on Call Basis – Develop QMS per ISO 9001 guide Line Developed Material Supplier ...
- Jul 08
Old Bridge, NJ
... Microsoft Office Quality inspection Microsoft Word CGMP Microsoft Excel Efficient verbal and written communication GDP Qualio (CAPA) Deacom (Inventory Control) Smartsheet (Data Entry) SAP ISO Certifications and Licenses HACCP Certification
- Jul 08
Dallas, TX
... Strategic Planning ISO-9001 / 16949 / 14001 / 13485 IQ-OQ, Validations, FAT P&L / Budgeting / AOP DFMEA, PFMEA, Control Plans, SPC High and Low Volume Production Capital Investment Problem Resolution / CAPA Automation / Robotics Account / Project ...
- Jul 07
Lexington, MA
... Participated in CAPA investigations by providing the lead investigator with data and process descriptions. Also assisted in writing Corrective and Preventive Actions to address potential issues in the testing process and offer guidance on how to ...
- Jul 07
East Hartford, CT
... Provided assistance in the creation and maintenance of a CAPA (corrective action preventive action) system Conducted study feasibility and site selection activities (Pre-study visits). Assisted with the development of study manuals, annotated CRFs, ...
- Jul 07
Windermere, FL
... Developed audit strategies, interfaced with internal and external SOX auditors, and resolved Quality Systems (QMS) audit issues, providing corrective actions CAPA. Oversaw small-scale data flow migration projects ensuring data integrity for FDA ...
- Jul 07
Mumbai, Maharashtra, India
... Effectively managed Data Integrity Issues with appropriate CAPA. Effectively handled “OOS/OOT/OOE investigation as per USFDA & MHRA guideline. Effectively managed Deviation & Lab incidence investigation and its trending as per predefined frequency ...
- Jul 07
Brockton, MA
... Areas of expertise Include: • Development, Design, Manufacturing of Medical Device Quality CAPA Risk Management NC Audit Mechanical system component selection and sizing Process automation Engineering change order Compliance Conduct root cause ...
- Jul 06
West Haven, CT
... LTSpice • Standards & Codes: NESC, IEEE, Utility Drafting Standards, ISO 9001, RTCA/DO-160, MIL-STD • QA/QC & Analysis: CAPA, Root Cause Analysis (RCA), Control Plans, PFMEA, Minitab, Excel • Programming & Tools: Embedded C, Python, Assembly, ...
- Jul 05