Quality System Specialist

Preferrednice to have

• Minimum of 2 years experience in area of quality systems, engineering, or equivalent experience preferred.
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.)
• Demonstrated knowledge of U.S., European, and international regulatory industry guidelines/standards and ability to interpret and apply.
• Knowledge and understanding of U.S. and International medical device regulations.
• Knowledge of supporting Quality Systems (audits, management review, quality planning, etc.)
• Strong communication, project management and influencing skills and have the ability to manage multiple tasks simultaneously.
• Strong written and oral communication and negotiation skills.
• Strong critical thinking skills.
• Developed problem-solving skills.
• Strong analytical skills.
• Demonstrated ability to successfully manage and complete projects in a matrix organization.
• Demonstrated ability to work independently.
• Experience working in a compliance-risk situation.
• Computer literacy, including Microsoft Word, Excel and PowerPoint.
• Some travel may be required.

• Support 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).
• Manage documents and document changes throughout QMS document lifecycle within electronic documentation system
• Facilitate engineering documentation management within electronic documentation system including DMR, DHF and technical standards.
• Perform change control/configuration management checks to engineering documentation to ensure compliance with local procedures
• Administer and maintain the electronic document management system, ensuring user access, permissions, and training records remain current.
• Perform document control checks to ensure documents and document changes comply with local procedures.
• Provide guidance to process owners, document creators, document reviewers and document approvers on the overall process and electronic management system.
• Identify improvements and inputs into the quality planning process
• Execute development and/or modifications of Stryker’s QMS
• Support Management Review and Quality Planning Review and related forums.
• Support GMP and GDP within Quality organization.
• Support QMS training development and delivery.
• Support implementation of best-in-class practices and benchmark against industry leaders and regulatory requirements.
• Support notified body communication.
• Ensure QMS reflects actual activities, business needs and supports NPD requirement.
• Coordinate internal and external audits, including securing conference rooms, communicating with SPOs/SMEs, and coordinating front room/back room logistics.
• Support internal and external audits by providing documentation and ensuring records are complete, accurate, and retrievable.