CAPA & Quality Compliance Specialist

Polymer Technology Systems, Inc; Town of Whitestown (NY); Vor Ort; USD 70.000 - 95.000; Vollzeit

Zusammenfassung

PTS Diagnostics seeks a Compliance Specialist to manage CAPA and drive regulatory compliance within the quality system. You will coordinate CAPA investigators, ensure timely actions, and maintain complete documentation.

Ideal candidates have 3+ years in medical device or pharma compliance, strong communication, and willingness to travel up to 10%. This is a full-time role based in Whitestown, IN with quality-focused responsibilities.

Qualifikationen

• Experience interpreting domestic and international regulations (FDA QMSR, ISO 13485).
• Strong written and verbal communication skills in English.
• Ability to travel up to 10% within the US.

Aufgaben

• Ensure regulatory compliance and optimize quality management procedures.
• Drive CAPA program activities with accountability for investigations and actions.
• Support audits and audit scheduling with proper documentation.

Kenntnisse

Regulatory compliance

CAPA management

Root cause analysis

Documentation accuracy

Effective communication

Ausbildung

Bachelor's or Associate’s degree (or related experience)

Tools

CAPA systems

Jobbeschreibung

PTS Diagnostics seeks a Compliance Specialist to manage CAPA and drive regulatory compliance within the quality system. You will coordinate CAPA investigators, ensure timely actions, and maintain complete documentation.

Ideal candidates have 3+ years in medical device or pharma compliance, strong communication, and willingness to travel up to 10%. This is a full-time role based in Whitestown, IN with quality-focused responsibilities.