Quality Assurance Leader, Medical Devices & Compliance

Putnam Plastics; Dayville (CT); On-site; USD 110,000 - 150,000; Full time

Job summary

Putnam Plastics is seeking a QA/RA Manager to oversee the quality management system and the QA/RA team. You will review procedures, lead internal and supplier audits, and drive continuous improvement to meet GMP and ISO 13485 requirements.

You will collaborate with cross-functional teams, ensure regulatory compliance, maintain documentation, and support customer inspections and change control processes.

Qualifications

• Bachelor’s degree in related technical or administrative field.
• 10+ years of supervisory experience in a regulated setting.
• 5 years in a regulated manufacturing organization.
• Strong knowledge of ISO 13485 and QMS practices.
• Experience with material compliance and regulatory standards.
• Experience establishing and maintaining a QMS with document control, change control, audits, CAPA and complaint handling.
• Proficient in MS Office; ERP/PLM/PDM familiarity.
• Demonstrated leadership and cross-functional collaboration.
• Strong analytical and communication skills.

Responsibilities

• Oversee and maintain the Quality Management System (QMS).
• Lead QA/RA team and ensure regulatory compliance across functions.
• Coordinate internal and external audits and customer inspections.
• Drive continuous improvement and cross-functional collaboration.
• Manage document control, change control and CAPA processes.

Skills

ISO 13485

QMS leadership

Regulatory compliance

CAPA & audits

eQMS knowledge

ERP/PLM familiarity

Regulatory standards

Document control

Analytical thinking

Communication skills

Education

Bachelor’s degree

Tools

eQMS software

Job description

Putnam Plastics is seeking a QA/RA Manager to oversee the quality management system and the QA/RA team. You will review procedures, lead internal and supplier audits, and drive continuous improvement to meet GMP and ISO 13485 requirements.

You will collaborate with cross-functional teams, ensure regulatory compliance, maintain documentation, and support customer inspections and change control processes.