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 worldÂ’s 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.
Responsible for reviewing and evaluating corrective/preventive actions (CAPA), the CAPA effectiveness program and communicating CAPA status to cross-functional departments and management.
·Participate in identifying the need for a CAPA to address non-conformances.
·Develop/review metrics for adverse trending analysis of non-conformaties.
·Support Cross Functional Teams in the investigations of non-conforming events and CAPA implementation.
·Review and evaluate CAPAs associated with non-conformance and regulatory audits.
·Review CAPAs to determine their effectiveness.
·Develop and provide metrics for CAPA status.
·Ensure on-time completion of CAPAs.
·Identify opportunities for continuous improvement.
·Interact with FDA and other regulatory agencies, as required.
·Work from verbal and/or written instructions.
·Knowledge of applicable international regulations and standards (QSR, MDD, ISO 13485, CMDCAS, etc.) and willingness to train others in quality assurance/GMP-related topics.
·Create / Revise SOPs associated with CAPA systems.
·Provide training for compliance to CAPA procedures.
·B.S./M.S. in engineering or sciences (mechanical, electrical, industrial, software, computer, biology, physics, chemistry, etc. )
·1-2 years experience desired.
·Engineering schematics/drawing/prints reading and interpretation
·Commitment to excellence and high standards
·Excellent interpersonal, written English and oral communication skills
·Excellent organizational, problem-solving, and analytical skills that lead to sound, timely decisions
·Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines
·Proficient with Microsoft Office
·Ability to deal effectively with a diversity of individuals at all organizational levels.
·Working knowledge of data collection, data analysis, evaluation, and scientific method.
·Sedentary Work: Exerting up to 10 lbs. of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, etc. Includes walking around the plant.
·Must be able to analyze and resolve non-routine product issues using independent judgment with the assistance of Quality and Engineering support when required.
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.
