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Director of Quality

Provides leadership and direction to the division?s quality team supporting the Cary, IL site to ensure achievement of business goals and objectives by ensuring distribution of quality products, as well as compliance with all applicable local, state and federal agencies and regulatory bodies.
Provides leadership for the division?s quality organization. Directs all quality activities to ensure new product development and product sustainment meet regulatory requirements and customer quality expectations. Develops, leads, and executes a Quality Strategy, ensuring that the Quality Strategy is appropriate and effective in meeting the business needs. Assures that the requirements of 21 CFR Part 820, 21 CFR Parts 210 and 211, ISO13485, ISO 14971 and any other applicable government or international standards are implemented and maintained. Establishes and maintains an Advanced Quality Engineering function that partners closely with new product development and aligns responsibilities with that of other functions. Oversees the quality and regulatory functions responsible for complaint handling, product improvement, and post-market regulatory reporting. Oversees the documentation required to meet regulatory requirements for all aspects of the QSR and international governing bodies. Oversees divisional participation in the reviewing of engineering designs to assure consideration for and compliance to Quality Assurance requirements and considerations. Defines, specifies, and/or approves of the implementation of standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy and reliability of company products. Establishes global standards for product design and sustainment supported by our quality teams. Reviews and approves new and changed quality system documentation for product and process development. Leads and participates in all internal and external audit activities. Provides expertise and guidance in interpreting governmental regulations, agency guidelines, and internal procedures to assure compliance, and then assists the organization in driving implementation. Participates in corporate development of methods, techniques, and evaluation criteria for projects, programs, and people. Responsible for the selection, supervision, development and objective setting for teams consisting of managers, individual contributors and clerical/technical staff. Works with the executive staff, regulatory affairs and quality assurance teams across the Corporation to achieve Stryker Medical?s mission, vision and objectives. Regularly communicates and drives the overall RA/QA vision, quality goals and achievements to all employees as well as to executive staff on a regular basis. Participates in interviews, sales meetings and customer site visits as appropriate. Supports new business opportunities and acquisitions. Supports the growth and development of the team as a whole by investing in employee involvement and development by fostering personal growth, being responsible and accountable, being passionate towards the success of the business and treating all with dignity and respect. Responsible for Quality team?s budget. Partners with quality leaders from other Stryker divisions and corporate to develop quality policies and procedures in support of division and corporate quality needs.
Work From Home: No
Travel Percentage: Up to 25%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer ? M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor?s legal duty to furnish information.
Stryker is one of the world?s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com


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