Quality Systems Specialist II: CAPA, NCMR & Compliance

Cirtec Services GmbH; Santa Clara (CA); Vor Ort; USD 84.000 - 100.000; Vollzeit

Zusammenfassung

Cirtec Medical, a leading contract developer/manufacturer for Class II and III medical devices, is seeking a Quality Systems Specialist II in California. The role ensures adherence to the QMS and coordinates elements within the Quality Systems & Control functions team.

The position emphasizes CAPA ownership, NCMR management, audit support, and cross-functional collaboration across R&D, Manufacturing, and QA to drive improvements and regulatory compliance.

Qualifikationen

• Associates of Science Degree in Manufacturing, Engineering, or Technical Field, or equivalent of directly transferrable industry work experience.
• Experience examining the data for patterns and trends and working on cross-functional teams.
• A minimum of 2 years of relevant experience in a regulated manufacturing environment.
• Knowledge of, and experience with, GMP/ISO Standards.
• Strong verbal and written English language communication skills.
• Must demonstrate ability and/or experience in computer use and general office software - Microsoft Office (Outlook, Word, Excel, PowerPoint).
• Hands-on self-starter with ability to work both independently and as part of a team.
• Must be able to read, write and speak fluent English.
• Ability to work with a wide variety of functional areas, including R&D, Manufacturing, and QA, as required accomplishing results with minimal guidance.

Aufgaben

• Initiate, own, and/or close Nonconforming Material Reports (NCMRs).
• Initiate or support investigation/analysis of returned/complaint materials.
• Coordinate activities related to NCM, Complaint, RMA, and CAPA processes.
• Support investigation and root cause analysis of advanced/complex issues.
• Escalate material nonconformances to CAPA system based on trending and monitoring analysis.
• Communicate product performance by formal presentations to management committees.
• Maintain quality system documents related to NCMR, CAPA, and Complaint systems.
• Initiate or review document changes including quality procedures.

Kenntnisse

Data pattern analysis

Cross-functional teamwork

Verbal & written English

Microsoft Office

GMP/ISO knowledge

Self-starter

Communication skills

Ausbildung

Associates degree in Manufacturing/Engineering/Technical field

Advanced post-secondary Ed./Certification (preferred)

Tools

PowerBI

Jobbeschreibung

Cirtec Medical, a leading contract developer/manufacturer for Class II and III medical devices, is seeking a Quality Systems Specialist II in California. The role ensures adherence to the QMS and coordinates elements within the Quality Systems & Control functions team.

The position emphasizes CAPA ownership, NCMR management, audit support, and cross-functional collaboration across R&D, Manufacturing, and QA to drive improvements and regulatory compliance.