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Associate CAPA Analyst Job
Date: May 5, 2012
Location: Mahwah, NJ, US
Requisition ID: 18557BR
Job Title: Associate CAPA Analyst
Division: Global Quality & Ops
Business Unit: U.S.
Business Functions: Manufacturing and Production
Focus Area General/Other: Production/Operations
Country: United States
State: NJ
City: Mahwah
Shift: N/A
Job Description:
Apply the NCR and CAPA processes and perform related administrative duties. Maintain product holds in the ERP system to prevent unauthorized shipment of product. Maintain records, monitor and analyze data through trend analysis. Support process improvement and systems integration projects.
- Maintain and develop local, divisional and corporate metrics.
- Perform trending activities.
- Maintain CAPA files and perform data entry.
- Place and maintain outbound holds on inventory in the ERP system to prevent unauthorized shipment of product.
- Assist in problem solving and root cause analysis activities.
- Assist in CAPA review meetings.
- Assist in CAPA process and system improvements.
- Assist in local training on systems and/or processes related to CAPA system.
- Assist in Stryker Orthopaedics’ continual improvement initiatives.
- Provide guidance on CAPA system requirements and expectations.
- Actively promote a team approach to the CAPA process across all departments and all plants.
Qualifications/Work Experience: • 0-3 years experience with Corrective Action in a regulated industry.
- Familiarity with Quality Management System requirements: FDA Quality System Regulation and ISO 13485.
- Demonstrated ability to use Word, Excel, Visio and Microsoft Project.
- Demonstrated ability to work with electronic systems to perform data analysis and trending.
- Demonstrated ability to collaborate with a diverse group of individuals.
Education and/or Special Training: Bachelor’s degree in Business, Engineering Science or related field. Related professional experiences may be considered in lieu of education. Prefer problem solving techniques certification/course completion and experience in a regulated industry.
Percent Travel Required: 5%
Job Title: Associate CAPA Analyst
Division: Global Quality & Ops
Business Unit: U.S.
Business Functions: Manufacturing and Production
Focus Area General/Other: Production/Operations
Country: United States
State: NJ
City: Mahwah
Shift: N/A
Job Description:
Apply the NCR and CAPA processes and perform related administrative duties. Maintain product holds in the ERP system to prevent unauthorized shipment of product. Maintain records, monitor and analyze data through trend analysis. Support process improvement and systems integration projects.
- Maintain and develop local, divisional and corporate metrics.
- Perform trending activities.
- Maintain CAPA files and perform data entry.
- Place and maintain outbound holds on inventory in the ERP system to prevent unauthorized shipment of product.
- Assist in problem solving and root cause analysis activities.
- Assist in CAPA review meetings.
- Assist in CAPA process and system improvements.
- Assist in local training on systems and/or processes related to CAPA system.
- Assist in Stryker Orthopaedics’ continual improvement initiatives.
- Provide guidance on CAPA system requirements and expectations.
- Actively promote a team approach to the CAPA process across all departments and all plants.
Qualifications/Work Experience: • 0-3 years experience with Corrective Action in a regulated industry.
- Familiarity with Quality Management System requirements: FDA Quality System Regulation and ISO 13485.
- Demonstrated ability to use Word, Excel, Visio and Microsoft Project.
- Demonstrated ability to work with electronic systems to perform data analysis and trending.
- Demonstrated ability to collaborate with a diverse group of individuals.
Education and/or Special Training: Bachelor’s degree in Business, Engineering Science or related field. Related professional experiences may be considered in lieu of education. Prefer problem solving techniques certification/course completion and experience in a regulated industry.
Percent Travel Required: 5%
Nearest Major Market: New Jersey
Job Segments: Administrative, Business Process, CAPA, Data, Data Analyst, Data Entry, Engineer, Engineering, ERP, Healthcare, Management, Medical, Orthopedic, Quality, Quality Manager, Technology