Job Title: CAPA Analyst Division: Stryker Orthopaedics Location: (Country - State) United States - New Jersey City or Sales Region: Mahwah Business Function: Manufacturing/Operations Shift: 1st Education and/or Special Training: EDUCATION Bachelor's Degree in Business, Engineering Science or related field. Related profressional experience may be considered in lieu of education. Prefer problem solving techniques certification/course completion. Job Description: JOB SUMMARY: * Apply the CAPA process and perform related activities. Monitor and analyze data and trending. Support activities for process improvements and systems integration projects.
ESSENTIAL DUTIES & RESPONSIBILITIES:
* Participate in CAPA process and system improvements. * Collaborate with CAPA administrators/analysts across all plants. * Participate in CAPA review meetings * Ensure compliance to the Divisional CAPA process requirements. * Perform trending activities. * Maintain and develop divisional metrics. * Communicate CAPA data and information to management. * Provide information, as appropriate, to feed into the corporate CAPA process. * Support Stryker Orthopaedics' continuous improvement initiatives. * Participate in divisional training on systems and/or processes related to CAPA System.
* 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: QUALIFICATIONS: * 2-5 years experience with Corrective Action in a regulated industry
* Applied knowledge of Quality Management System requirements: ISO 9001 / 13485 and FDA Quality System Regulation
* Demonstrated ability to use Word, Excel, Visio, and Microsoft Project
* Demonstrated ability to use appropriate problem solving techniques
* Demonstrated ability to facilitate root cause investigations and analysis
* Demonstrated ability to work with electronic systems to perform data analysis, trending and system configuration activities
* Demonstrated ability to collaborate with a diverse group of individuals
Percent Travel Required up to 25% Requisition ID: 10979BR
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