Quality System Specialist

Stryker•Redmond, WA

1d•Hybrid

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 applicable regulatory requirements. The role ensures the QMS meets internal and external requirements necessary for regulatory clearance and certification. This is a hybrid position based in Redmond, Washington. The specialist manages QMS and engineering documentation through electronic systems, supports change and configuration management, maintains document-system access and training records, and advises process owners and document contributors. The role also contributes to quality planning, management reviews, QMS training, GMP and GDP practices, and the adoption of industry best practices. It supports notified-body communications and coordinates and assists with internal and external audits, including documentation and audit logistics. Some travel may be required; the posting also 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.
Computer literacy, including Microsoft Word, Excel, and PowerPoint.
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.

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, or TUV.
Knowledge of U.S., European, and international regulatory industry guidelines and standards, and 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.

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 documentation processes and the electronic management system.
Identify improvements and provide input to the quality planning process.
Execute development or modification 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 conference-room arrangements, communications with SPOs and SMEs, and front-room and back-room logistics.
Support internal and external audits by providing documentation and ensuring records are complete, accurate, and retrievable.