Quality System Specialist – Hybrid (Redmond)

Stryker; Redmond; Hybrid; AUD 111,000 - 170,000; Full time

Job summary

Stryker in Redmond, Washington is seeking a Quality System Specialist to support the development and maintenance of the quality management system in line with regulatory requirements for medical devices. The role is hybrid in Redmond, WA and collaborates across functions to ensure QMS compliance and readiness for regulatory clearance.

The ideal candidate has a background in science or engineering, 0–2 years in manufacturing, and knowledge of FDA/ISO guidelines with strong communication and

Qualifications

• Bachelor's degree in science, engineering or related discipline or equivalent experience.
• 0–2 years experience in manufacturing environment or equivalent.

Responsibilities

• Support QMS compliance with regulatory requirements (FDA, ISO, MDD, etc.).
• Manage documents and document changes in the electronic documentation system.
• Facilitate engineering documentation management (DMR, DHF, technical standards).
• Perform change control/configuration checks for engineering documentation.

Skills

Regulatory knowledge

Documentation management

QMS

Communication

Project management

Education

Bachelor's degree in science/engineering

Tools

MS Word

MS Excel

PowerPoint

Job description

Stryker in Redmond, Washington is seeking a Quality System Specialist to support the development and maintenance of the quality management system in line with regulatory requirements for medical devices. The role is hybrid in Redmond, WA and collaborates across functions to ensure QMS compliance and readiness for regulatory clearance.

The ideal candidate has a background in science or engineering, 0–2 years in manufacturing, and knowledge of FDA/ISO guidelines with strong communication and