QA Specialist – ISO 13485 & GMP Compliance

Polysciences, Inc; Warrington Township (Bucks County); On-site; USD 85,000 - 110,000; Full time

Job summary

Polysciences, Inc. in Warrington, PA is seeking an experienced Quality Assurance Specialist to maintain and improve the QMS, ensuring regulatory compliance across ISO 13485 and 21 CFR Part 820.

You will investigate quality issues, lead CAPAs, support audits, and collaborate with Manufacturing, R&D, and Engineering to drive continuous improvement. The role emphasizes investigations, documentation, and cross-functional teamwork in a regulated manufacturing environment, with a focus on product

Qualifications

• High school diploma or GED.
• 5+ years of experience in ISO 13485 and/or 21 CFR Part 820 regulated environment.
• GMP and GDP knowledge.
• Experience supporting internal and external audits and maintaining regulatory compliance.
• Familiarity with quality management processes including CAPAs, nonconformances, change controls, and investigations.
• Strong analytical, problem-solving, and organizational skills.
• Excellent written and verbal communication with cross-department collaboration.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.
• Proficiency in Microsoft Office and document management systems.

Responsibilities

• Maintain and improve the QMS in line with ISO 13485, FDA and GMP.
• Manage nonconformances, CAPAs, change controls and deviations.
• Review and approve quality documentation for compliance.
• Disposition incoming, in-process and finished materials.
• Conduct internal audits and support regulatory inspections.

Skills

Quality systems

Regulatory compliance

Auditing

CAPA

Investigations

Documentation

Cross-functional collaboration

Analytical thinking

Communication

Project management

Education

High School Diploma/GED

Bachelor's degree in Chemistry, Biology, Engineering, Quality Assurance, or related

Tools

Microsoft Office

Document management systems

ERP systems

eQMS

Job description

Polysciences, Inc. in Warrington, PA is seeking an experienced Quality Assurance Specialist to maintain and improve the QMS, ensuring regulatory compliance across ISO 13485 and 21 CFR Part 820.

You will investigate quality issues, lead CAPAs, support audits, and collaborate with Manufacturing, R&D, and Engineering to drive continuous improvement. The role emphasizes investigations, documentation, and cross-functional teamwork in a regulated manufacturing environment, with a focus on product