Medical Device Quality Engineer — CAPA, KPIs & Compliance

Putnam Plastics Corporation; Dayville (CT); On-site; USD 70,000 - 90,000; Full time

Job summary

Putnam Plastics Corporation in Dayville, CT seeks a Level 1 Quality Engineer to develop and maintain quality standards, plans, and procedures ensuring product and process compliance with regulatory and internal requirements. The role emphasizes cross-functional teamwork and continuous improvement across production, supplier quality, and development programs.

You will participate in audits, support CAPA activities, evaluate verification/validation protocols, and review controlled documents.

Qualifications

• Bachelor's degree in engineering or science or equivalent work experience.
• Minimum 2 years of manufacturing experience in a QMS environment.
• Working knowledge ISO 13485:2016 and FDA requirements (21 CFR 820).
• Experience with eQMS such as ETQ, Green Light Guru, MasterControl, Qualio, or Veeva.
• Knowledge of QA methods such as process validations, SPC, and protocol/report writing.

Responsibilities

• Performs activities to ensure compliance with quality objectives and regulatory requirements.
• Investigates customer complaints, performs return sample evaluations, root cause analysis, and implements changes to the quality system when needed; communicates final reports to the customer.
• Evaluates verification and validation protocols and reports to ensure compliance to external standards and internal standards and procedures.
• Participates and leads CAPA's as needed.
• Evaluates RISK during reviews of non-conformings.
• Responsible for and facilitates the development and implementation of quality engineer metrics as KPIs.
• Review and approves controlled documents to ensure defined quality objectives are met.
• Assist in the implementation and further development of quality and regulatory policies and procedures.

Skills

Quality Assurance

Regulatory Knowledge

CAPA Management

Root Cause Analysis

Documentation

Continuous Improvement

Statistical Methods

Education

Bachelor's Degree in Engineering or Science

ASQ Certification

Tools

ETQ

Green Light Guru

MasterControl

Qualio

Veeva

Minitab

Job description

Putnam Plastics Corporation in Dayville, CT seeks a Level 1 Quality Engineer to develop and maintain quality standards, plans, and procedures ensuring product and process compliance with regulatory and internal requirements. The role emphasizes cross-functional teamwork and continuous improvement across production, supplier quality, and development programs.

You will participate in audits, support CAPA activities, evaluate verification/validation protocols, and review controlled documents.