Engineer - Quality L1

Putnam Plastics Corporation; Dayville (CT); Vor Ort; USD 70.000 - 90.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Quality Assurance

Regulatory Knowledge

CAPA Management

Root Cause Analysis

Documentation

Continuous Improvement

Statistical Methods

Ausbildung

Bachelor's Degree in Engineering or Science

ASQ Certification

Tools

ETQ

Green Light Guru

MasterControl

Qualio

Veeva

Minitab

Jobbeschreibung

Putnam Plastics Corporation (PPC) is the industry leading manufacture of life-saving medical devices components for over 40 years. We are looking for people who want to invest in their future, the future of PPC and our PPC community. Please refer to our website at putnamplastics.com/about/career-opportunities for more information.

This is a summary only. We are an EEO employer.

TheQuality Engineer L1, in support of production, supplier quality, and development programs, is responsible for developing and maintaining quality standards, plans, and procedures to assure our products and processes meet required specifications, regulatory standards, and system requirements. A dedication to both company and departmental continuous improvement is required. Position includes cross functional team participation.

• Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
• Investigates customer complaints, performs return sample evaluations, root cause analysis, and implements changes to the quality system when needed upon investigation communicate 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-conforming's.
• Responsible for and facilitates the development and implementation of quality engineer metrics as KPIs. (Key Performance Indicators).
• 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.
• Tracks reoccurring quality and compliance-related activates with Supplier Quality.

Audits:

• Participates in audits, customer meetings, support internal audits within the organization and tracks compliance of corporate QMS to applicable standards.
• Knowledge base remains current of existing and emerging regulations, standards, or guidance documents including Medical Device Regulation (MDR) and all other standards /regulations including within scope as they pertain to training.

Required Qualifications:

• Bachelor's degree in engineering or science, or equivalent work experience.
• A minimum of two (2) years related to manufacturing experience in a QMS environment.
• Working knowledge ISO 13485:2016 and FDA requirements (21 CFR 820) and other equivalent applicable standards.
• Prior experience within electronic Quality Management Systems (eQMS) such as ETQ, Green Light Guru, Master Control, Qualio, Veeva, or similar applications and systems, as well as Minitab or other Statistical Programs.
• Knowledge of Quality Assurance methods, such as process validations, statistical process control, design of experiments, and protocol/report writing.

Preferred Qualifications:

• Bachelor's Degree in a technical field: plastics, mechanical, chemical, or biomedical engineer field and at least 5 years of relevant experience OR the equivalent combination of education.
• At least 5 years of direct experience in a medical device company or similarly regulated environment with related Supplier Quality Engineer experience in a medical device or Pharma Company.
• Working knowledge of Quality KPI and SPC.
• Certification in training methods or ASQ Certifications such as Quality Engineer or Quality Auditor.