Quality Systems Specialist II - Medical Devices & CAPA

Cirtec Services GmbH; Santa Clara (CA); On-site; USD 84,000 - 100,000; Full time

Benefits offered by this job

Training and career development

Healthcare and well‑being programs

Paid Time Off and 401(k) with company

Job summary

Cirtec Medical is seeking a Quality Systems Specialist II to ensure adherence to the Quality Management System (QMS) and coordinate elements across Quality Systems & Control. You will drive CAPA, NCMR, and complaint processes while maintaining critical quality documents.

You will collaborate with R&D, Manufacturing, and QA to investigate issues, support audits, and train teams on QMS requirements. A degree in manufacturing/engineering and 2+ years in a regulated setting are preferred.

Qualifications

• Must have strong verbal and written English communication skills.
• Experience in GMP/ISO standards.
• Hands‑on, self‑starter with ability to work independently or in a team.
• Reading, writing and speaking fluent English.

Responsibilities

• Initiate, own, and close Nonconforming Material Reports (NCMRs).
• Investigate/analyze returned/complaint materials.
• Coordinate NCM, Complaint, RMA, and CAPA processes.
• Support root cause analysis of complex issues.
• Provide training on NCM Control, CAPA, and related QMS elements.
• Support internal and external audits.

Skills

Verbal and written English

Microsoft Office

Cross‑functional collaboration

GMP/ISO knowledge

Hands‑on self‑starter

Education

Associates of Science Degree in Manufacturing/Engineering/Tech

Advanced post‑secondary education in Manufacturing/Engineering

Tools

PowerBI

Job description

Cirtec Medical is seeking a Quality Systems Specialist II to ensure adherence to the Quality Management System (QMS) and coordinate elements across Quality Systems & Control. You will drive CAPA, NCMR, and complaint processes while maintaining critical quality documents.

You will collaborate with R&D, Manufacturing, and QA to investigate issues, support audits, and train teams on QMS requirements. A degree in manufacturing/engineering and 2+ years in a regulated setting are preferred.