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
