Quality System Specialist

As the Quality System Specialist you will support the development of the quality management system in accordance with relevant regulatory requirements for medical devices. Oversee, support, and ensure that an effective and efficient quality management system is built and maintained. Responsibility for ensuring that all applicable quality system regulations are met in order to receive regulatory clearance/certification. This role is Hybrid in Redmond, Washington.

What you will do

• 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.

What you need

• Bachelor’s Degree in a science, engineering or related discipline, or equivalent experience
• 0-2 years experience in manufacturing environment or equivalent.

Preferred

• 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.

United States of America Pay Ranges:

• US15 : $76,500 - $117,100 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.