Director, Quality Systems

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 world’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

The Director, Quality Systems is responsible for the global deployment and continuous improvement of Stryker Biotech Quality Systems to meet the needs of the Company s quality policy and objectives as well as to ensure compliance with national and international regulations. The Director Quality Systems is responsible to direct the efforts of the internal auditing function overseeing the master schedule for internal and external supplier audits and to trend and benchmark compliance objectives to world wide health authority and industry standards. The Director Quality Systems is responsible to direct the efforts of the Validation group, mandating and overseeing the compliant execution of validation activities in concurrence with the validation master plan. The Director Quality Systems is responsible as the Management Representative for Stryker Biotech. 1. Responsible for Quality policy and quality systems to be deployed across all Stryker Biotech sites.2. Responsible for annual management review process to Senior Management and to define with the Quality Site Heads the Quality mandates and objectives to ensure compliance and continuous improvement.3. Responsible to direct the quality systems and training group.4. Responsible to direct the internal audit group. To include the master audit schedule for internal and supplier related external audits as well as track and trend corrective actions resultant from all audit activity.5. Responsible to apprise the division of compliance trends and to foster the increasing technical knowledge of the Quality organization on Quality systems and compliance. Responsible for management of GMP and Quality systems training programs.6. Responsible for the direction of the validation group. To include Quality Validation oversight across all validation plans.7. Responsible to lead, develop and recruit a highly effective quality staff of appropriate technical depth to support site Quality Systems functions. 8. Responsible to support and develop Company Quality initiatives in conjunction with VP Quality and Site heads of Quality.9. Responsible to be a productive member of the Stryker Biotech Quality management team, such that Quality initiatives, accountability, teamwork and leadership are fostered. 10. Maintain an up to date working knowledge of national and international standards and guidelines.Master s Degree or equivalent by experience, preferably in a scientific or health related discipline. Eight or more years Quality management experience in Quality Assurance, Quality Systems or related discipline in a pharmaceutical, biopharmaceutical, biotechnology or relevant medical device industry. Experience with US and International Regulatory requirements necessary. Successful leadership of people and management of projects are essential. Ability to work in a matrix team environment with a focus of meeting key internal customer needs is essential. Excellent communication, negotiating and influencing skills are required.See QualificationsStryker 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.com