Position SummaryProvide quality engineering leadership and direction in quality assurance, control, and preventative activities with a focus on continuous improvement of products and processes. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance to regulation and standards.
What You'll Do:Work closely with operations and the business functions to ensure quality performance of product and processes.Work closely with customers, sales/marketing/field personnel, and cross-functional teams to address top quality issues.Mentor, provide oversight, and approval of NC/CAPA, and act as a high-level expert in problem-solving and root-causing activities.Initiate and lead in the development and improvement of the manufacturing processes for existing products.Oversee and lead investigations during concession management.Review and approve change management activities, challenge effectiveness, and drive strong review.Interpret KPI trends and drive continuous improvement processes.Advocate for Human Factor practices and proficiency in the science of identification of mitigation.Serve as a subject matter expert in risk management practices and concepts.Develop and provide input by identifying opportunities and weaknesses.Provide technical direction in optimization of inspection methods and sampling.Exhibit high proficiency in statistical methods and application.Engage in and may lead internal and external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business.Aid in the development of validation strategies for existing products.Support manufacturing transfers to other plants/facilities, leading quality activities.Be responsible for initiation, internal containment, and support of ship and product holds for potential product escapes.Coach and mentor others in quality topics and activities. What You'll Need:BS in a science, engineering or related discipline.MS, CQE, or CRE preferred.Six Sigma Green or Black belt preferred.Minimum of 5 years experience preferred.Prior divisional or site experience desired.Previous industry experience required.Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.Understanding of US and International Medical Device Regulations.Familiarity with ISO 13485, GDP, GMP required.Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).Must possess strong communication, project management, and influencing skills as well as have the ability to manage multiple tasks simultaneously.Ability to represent Quality function within and across project teams.Strong interpersonal skills, written, oral communication and negotiation skills.Strong in critical thinking and outside-the-box thinking.Highly developed problem-solving skills and strong analytical skills.Demonstrated ability to successfully manage and complete projects in a matrix organization.Demonstrated ability to work independently and as part of cross-functional teams.Experience in working in a compliance risk situation.Computer literacy.Some travel may be required. Subject matter expert for the regulatory and Stryker-business requirements of their area of ownership.Effective communicator and consensus-builder.Proven ability to implement large-scale projects on a broad scale.
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