QA Specialist: ISO 13485, CAPA & Audit

Polysciences; Warrington Township (Bucks County); On-site; USD 76,900 - 92,300; Full time

Benefits offered by this job

Competitive Wages

Generous Year-end Bonus

Comprehensive Benefits

Job summary

Polysciences is seeking a Quality Management professional in Warrington, PA. The role demands 5+ years experience in ISO 13485 and 21 CFR 820 regulations, ensuring compliance and maintaining quality management systems.

The qualified candidate will collaborate with multiple departments to uphold product quality and regulatory standards and will have additional benefits including competitive wages and additional training opportunities.

Qualifications

• 5+ years of experience working under ISO 13485 and 21 CFR 820 regulations.
• Strong analytical and problem-solving abilities.
• Experience with audit preparedness for internal and external audits.

Responsibilities

• Implement and maintain the company’s quality management system (QMS).
• Conduct internal audits and participate in external audits.
• Lead investigations into product non-conformities and develop corrective actions.

Skills

Quality Management Systems

Good Manufacturing Practices

Analytical Skills

Organizational Skills

Communication Skills

Document Management Software

Education

4 Year Degree

Tools

Microsoft Office Suite

ERP Systems

Job description

Polysciences is seeking a Quality Management professional in Warrington, PA. The role demands 5+ years experience in ISO 13485 and 21 CFR 820 regulations, ensuring compliance and maintaining quality management systems.

The qualified candidate will collaborate with multiple departments to uphold product quality and regulatory standards and will have additional benefits including competitive wages and additional training opportunities.