Quality Management System (QMS) Administrator

Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team.

Job Title:Quality Management System (QMS) Administrator

Location(s): Issaquah, WA

(Hybrid: Onsite Tuesdays and Thursdays)

Job Description:

The Quality Management System (QMS) Administrator is responsible for supporting administrative tasks associated with the Document Control and Change Management QMS process, as well as other QMS-related compliance project activities. This role requires strong attention to detail, effective communication, and a willingness to adapt to changing business needs.

• Acts in an administrative support capacity for critical QMS processes such as Document. Control and Change Management and QMS compliance projects.
• Review quality records for all related areas of responsibility.
• Generate, review, and maintain QMS documents.
• Other responsibilities as needed.

• Associate or bachelor's degree in business administration, scientific discipline, or equivalent experience.
• 1+ years of Quality Management System (QMS) experience working in a regulated Good Manufacturing Process (GMP) environment.
• Advanced knowledge of Microsoft Office applications, especially Word and Excel.

• Capacity to work both independently and in a team-oriented environment.
• Ability to effectively complete the tasks entrusted.
• Capacity to quickly adapt to changing priorities and timelines.
• Strong oral and written communication skills.
• Ability to learn quickly and pay attention to detail.

• Practical experience in a regulated industry.
• Knowledge of international standards such as ISO 13485 and 21 CFR 820.
• Use of electronic quality management systems such as ETQ, Trackwise, Smart Slove.
• Project Management.

• Proficiency in Microsoft Office (Word, Outlook, Excel for tracking, Teams).
• Basic familiarity with QMS systems.
• Ability to manage multiple projects daily.
• Strong communication skills; must be comfortable speaking in meetings.
• Team collaboration via MS Teams.

• Technical writing.
• Experience in the medical device industry.
• Familiarity with FDA regulations.

• Strong administrative skills.
• Ability to provide feedback and hold team members accountable.
• Extroverted personality.
• Team leadership experience.
• Project tracking capabilities.

Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.