QA Specialist: GMP/ISO for Medical Devices

Plastikon Industries Inc; Lawrence (KS); Sur place; USD 60 000 - 86 000; Plein temps

Résumé du poste

Plastikon Healthcare is seeking a Quality Assurance Specialist to strengthen our QA/QMS across pharmaceutical and medical-device manufacturing. You will support regulatory compliance, patient safety, and continuous improvement while maintaining the QMS and controlled documents.

You will review batch and device history records, manage deviations and CAPAs, assist with change control, and participate in internal audits and inspections.

Qualifications

• Bachelor’s degree in life sciences, chemistry, engineering, or biology.
• 1–3+ years QA/QC/manufacturing/regulatory in GMP/pharma/medical-device environments.
• Knowledge of CAPA, document control, deviation/nonconformance handling, change control, investigation practices.
• Familiarity with 21 CFR Part 11, 21 CFR Part 820, 210/211, and ISO 13485.
• Strong technical writing and attention to detail.
• Experience using electronic QMS platforms preferred.

Responsabilités

• Maintain and improve the Quality Management System (QMS) aligned to procedures and regulatory requirements.
• Review and control documents (SOPs, work instructions, forms, specifications) and lifecycle management.
• Review batch records and device history records for accuracy and release readiness.
• Identify, document, triage, and disposition deviations and nonconformances; ensure timely escalation.
• Initiate and track CAPAs including effectiveness checks and closures.
• Support change control activities, including impact assessments and approvals.
• Participate in root-cause investigations and document conclusions with data-driven recommendations.
• Plan and conduct internal audits; verify closures and audit readiness.
• Support inspections by customers, FDA, and notified bodies with prepared documentation.
• Collaborate cross-functionally to resolve quality issues and prevent recurrence.
• Trend quality metrics and communicate insights for continuous improvement.

Connaissances

Quality assurance

Documentation

Regulatory knowledge

Attention to detail

Formation

Life sciences degree

Engineering degree

Outils

eQMS platforms

Description du poste

Plastikon Healthcare is seeking a Quality Assurance Specialist to strengthen our QA/QMS across pharmaceutical and medical-device manufacturing. You will support regulatory compliance, patient safety, and continuous improvement while maintaining the QMS and controlled documents.

You will review batch and device history records, manage deviations and CAPAs, assist with change control, and participate in internal audits and inspections.