Senior Specialist, Quality Management Systems

Company: Katalyst Healthcares & Life Sciences
Location: Mahwah
Posted on: June 23, 2022

Job Description:

Job DescriptionResponsibilities: Lead and participate in local and global change management projects, ensuring appropriate outcomes and compliance, particularly in those areas related to Quality Systems. Champion continuous process improvement throughout Quality Systems/Change Management and the rest of the Stryker organization. Supports QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, MDD, and individual country requirements). Ensure optimum state of QMS for current and future business needs. Identify and deliver strategic and futuristic improvements in areas of responsibility. Oversee and execute development and/or modification of Stryker's QMS. Support Management Review and Quality Planning Review and related forums. Assess and quantify requirements for QMS to optimize organizational structure in areas of responsibility. Ensure GMP and GDP compliance within Quality organization. Provide guidance for the development, maintenance, and improvement of policies and procedures to increase the efficiency and effectiveness of the QMS. Ensure development and delivery of QMS training in areas of expertise. Provide individualized mentoring for team members. Contribute to the development, maintenance, and improvements of policies and procedures. Implement best-in-class practices and benchmark against industry leaders and regulatory requirements. Liaise and communicate with notified bodies to manage certification changes. Ensure QMS reflects actual activities, business needs and supports NPD requirements. Engage in relevant QMS IS discussions. Basic project management understanding. Key contributor to QMS business process(as) and understand IS system support requirements. Support internal and external quality system audits. Understands system integration. Support IS change control assessment and approval.Requirements: BS in a science, engineering, business or related discipline. 3 years experience in manufacturing environment or equivalent preferred. Experience in regulated environment and interaction with regulatory agencies required. Thorough knowledge and understanding of US and International Medical Device Regulations. Strong knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.) Strong communication, project management and influencing skills. Ability to plan, organize, and implement multiple concurrent tasks. Strong interpersonal skills, written, oral communication and negotiations skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization. Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions. Demonstrated ability to work in cross-functional team environments. Basic understanding of compliance risk situations. Computer literacy. Some travel may be required.

Keywords: Katalyst Healthcares & Life Sciences, Paterson , Senior Specialist, Quality Management Systems, Executive , Mahwah, New Jersey