Sr. CAPA Analyst
| Company | Stryker |
| Location | Mahwah, NJ |
| Discipline | Other Engineering |
| Posted | 11-06-2009 |
Job Description
Stryker is an exceptional company with exceptional people who deliver exceptional results. We have differentiated ourselves by advancing meaningful innovations, creating cost-effective solutions for and improving the lives of our global customers and patients. As a winner of the 2007 and 2008 Gallup Great Workplace Award, we have demonstrated that Stryker has one of the most productive and engaged workforces in the world.
Our exceptional results fuel ongoing opportunities for Stryker employees to build outstanding careers and to develop and grow both personally and professionally. Our work environment attracts many different kinds of talented and driven people who love to win and serve others. We always put quality first. We hold ourselves accountable to reach or exceed our goals and continually improve everything we do. These attributes are shared by the employees that make up Stryker. They are the things that bring us together and serve as the foundation of all we do. And they are the enablers of both our past and future success.
Stryker is one of the worlds leading medical technology companies with the most broadly based range of products in orthopaedics and a significant presence in other medical specialties. The Company's products include implants used in joint replacement, trauma, craniomaxillofacial and spinal surgeries; biologics; surgical, neurologic, ear, nose & throat and interventional pain equipment; endoscopic, surgical navigation, communications and digital imaging systems; as well as patient handling and emergency medical equipment. For more information about Stryker, please visit the company web site at: http://www.stryker.com.
JOB SUMMARY:
Facilitate CAPA process and related activities. Create CAPAs; monitor and analyze data and trending. Lead and/or support activities for process improvements and systems integration projects.
ESSENTIAL DUTIES & RESPONSIBILITIES:
• Lead and participate in CAPA process and system improvements.
• Ensure CAPA activities are effectively coordinated across all plants/locations.
• Facilitate/participate in CAPA review meetings.
• Ensure compliance to the Divisional CAPA process requirements across all plants.
• Perform trending activities.
• Maintain 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.
• Lead and participate in projects related to system integration and improvements to the Solution NetRegulus system as it relates to CAPA.
• Perform system administration activities in NetRegulus.
• Perform and participate in divisional training on systems and/or processes related to CAPA.
• Actively promote a team approach to the CAPA process across all departments and all plants.
QUALIFICATIONS:
• 5+ years experience addressing Corrective Actions in a regulated industry
• Demonstrated knowledge of Quality Management System requirements: FDA Medical Device regulations (QSR) requirements, ISO 9001 / 13485, and applicable Medical Device Directives
• Demonstrated ability to use Word, Excel, Visio, and Microsoft Project
• Demonstrated ability to effectively apply problem solving techniques
• Demonstrated ability to effectively facilitate meetings to determine root cause investigations and analysis
• Demonstrated ability to work with electronic systems to complete/evaluate data analysis, trending, and system configuration
• Demonstrated ability to collaborate with individuals across multiple plants/locations
• Demonstrated ability to manage projects
EDUCATION
• Bachelor's Degree in Business, Engineering Science or related field of study.
• Prefer formal problem solving techniques training and/or certification.
Stryker is an equal employment opportunity/affirmative action employer committed to hiring a diverse workforce. To read more about Stryker, please visit our website at www.stryker.jobs. Additional Information Reference Code:9709BR. Contact Information: Stryker www.stryker.com
Our exceptional results fuel ongoing opportunities for Stryker employees to build outstanding careers and to develop and grow both personally and professionally. Our work environment attracts many different kinds of talented and driven people who love to win and serve others. We always put quality first. We hold ourselves accountable to reach or exceed our goals and continually improve everything we do. These attributes are shared by the employees that make up Stryker. They are the things that bring us together and serve as the foundation of all we do. And they are the enablers of both our past and future success.
Stryker is one of the worlds leading medical technology companies with the most broadly based range of products in orthopaedics and a significant presence in other medical specialties. The Company's products include implants used in joint replacement, trauma, craniomaxillofacial and spinal surgeries; biologics; surgical, neurologic, ear, nose & throat and interventional pain equipment; endoscopic, surgical navigation, communications and digital imaging systems; as well as patient handling and emergency medical equipment. For more information about Stryker, please visit the company web site at: http://www.stryker.com.
JOB SUMMARY:
Facilitate CAPA process and related activities. Create CAPAs; monitor and analyze data and trending. Lead and/or support activities for process improvements and systems integration projects.
ESSENTIAL DUTIES & RESPONSIBILITIES:
• Lead and participate in CAPA process and system improvements.
• Ensure CAPA activities are effectively coordinated across all plants/locations.
• Facilitate/participate in CAPA review meetings.
• Ensure compliance to the Divisional CAPA process requirements across all plants.
• Perform trending activities.
• Maintain 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.
• Lead and participate in projects related to system integration and improvements to the Solution NetRegulus system as it relates to CAPA.
• Perform system administration activities in NetRegulus.
• Perform and participate in divisional training on systems and/or processes related to CAPA.
• Actively promote a team approach to the CAPA process across all departments and all plants.
QUALIFICATIONS:
• 5+ years experience addressing Corrective Actions in a regulated industry
• Demonstrated knowledge of Quality Management System requirements: FDA Medical Device regulations (QSR) requirements, ISO 9001 / 13485, and applicable Medical Device Directives
• Demonstrated ability to use Word, Excel, Visio, and Microsoft Project
• Demonstrated ability to effectively apply problem solving techniques
• Demonstrated ability to effectively facilitate meetings to determine root cause investigations and analysis
• Demonstrated ability to work with electronic systems to complete/evaluate data analysis, trending, and system configuration
• Demonstrated ability to collaborate with individuals across multiple plants/locations
• Demonstrated ability to manage projects
EDUCATION
• Bachelor's Degree in Business, Engineering Science or related field of study.
• Prefer formal problem solving techniques training and/or certification.
Stryker is an equal employment opportunity/affirmative action employer committed to hiring a diverse workforce. To read more about Stryker, please visit our website at www.stryker.jobs. Additional Information Reference Code:9709BR. Contact Information: Stryker www.stryker.com
How to Apply
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