Quality System Specialist
About The Position
The Quality System Specialist supports the development, implementation, and maintenance of an effective quality management system (QMS) for medical devices in accordance with relevant regulatory requirements. The role helps ensure applicable quality system regulations are met to support regulatory clearance and certification. This is a hybrid position in Redmond, Washington. The specialist supports QMS compliance with internal and external requirements, manages quality and engineering documentation through electronic systems, and performs document control and change-control checks. The role provides guidance to process owners and document stakeholders, supports quality planning and management review, contributes to QMS development and training, and helps ensure the QMS reflects actual activities, business needs, and new product development requirements. The position also supports notified-body communications and coordinates and assists with internal and external audits, including audit logistics and the provision of complete, accurate, and retrievable records. Some travel may be required, although the posting lists a travel percentage of none.
Requirements
- Bachelor’s degree in a science, engineering, or related discipline, or equivalent experience.
- 0–2 years of experience in a manufacturing environment or equivalent.
- Demonstrated knowledge of U.S., European, and international regulatory industry guidelines and standards, with the ability to interpret and apply them.
- Knowledge and understanding of U.S. and international medical device regulations.
- Knowledge of supporting quality systems, including audits, management review, and quality planning.
- Strong communication, project management, and influencing skills, with 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.
- Ability to successfully manage and complete projects in a matrix organization.
- Ability to work independently.
- Experience working in a compliance-risk situation.
- Computer literacy, including Microsoft Word, Excel, and PowerPoint.
Nice To Haves
- At least 2 years of experience in quality systems, engineering, or equivalent experience.
- Experience interacting with regulatory agencies such as FDA, MoH, and TUV.
- Some travel may be required.
Responsibilities
- Support QMS compliance with applicable internal and external regulatory requirements, including site, division, corporate, FDA, ISO, MDD, and individual-country requirements.
- Manage documents and document changes throughout the QMS document lifecycle in the electronic documentation system.
- Facilitate engineering documentation management in the electronic documentation system, including DMR, DHF, and technical standards.
- Perform change-control and configuration-management checks on engineering documentation to ensure compliance with local procedures.
- Administer and maintain the electronic document management system, including keeping user access, permissions, and training records current.
- Perform document-control checks to ensure documents and document changes comply with local procedures.
- Guide process owners, document creators, reviewers, and approvers on the overall process and electronic management system.
- Identify improvements and provide inputs to the quality planning process.
- Execute development and/or modifications of Stryker’s QMS.
- Support Management Review, Quality Planning Review, and related forums.
- Support GMP and GDP within the Quality organization.
- Support development and delivery of QMS training.
- Support implementation of best-in-class practices and benchmarking against industry leaders and regulatory requirements.
- Support notified-body communication.
- Ensure the QMS reflects actual activities and business needs and supports NPD requirements.
- Coordinate internal and external audits, including arranging conference rooms, communicating with SPOs and SMEs, and coordinating front-room and back-room logistics.
- Support internal and external audits by providing documentation and ensuring records are complete, accurate, and retrievable.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
