Technical Quality Engineer, Medical Devices

Putnam Plastics; Dayville (CT); On-site; USD 80,000 - 110,000; Full time

Job summary

Putnam Plastics Corporation (PPC) is seeking a Technical Quality Engineer to apply quality and process engineering principles to investigate, analyze, and optimize processes for ongoing product quality and regulatory compliance. You will participate in continuous improvement and support documentation, validation, and CAPA activities.

The role requires hands-on use of metrology equipment, review of CTQs, and collaboration with supply chain, R&D, and operations to reduce variability and drive

Qualifications

• Bachelor’s degree in Engineering or Science, or equivalent work experience.
• Minimum of three years related quality experience in a regulated manufacturing environment.
• Working knowledge of ISO 9001, ISO 13485 or other regulated manufacturing industries.
• Direct experience with metrology equipment.
• Direct experience authoring and participating in validation activities.
• Familiarity with Minitab or other statistical software.
• Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint, Project, Visio, SharePoint, Teams).
• Strong analytical, technical and interpersonal skills.
• Ability to work independently and in a team.
• Ability to handle multiple tasks with time management.

Responsibilities

• Advocate to ensure processes are compliant and documented.
• Review and evaluate product specifications and CTQ attributes.
• Hands-on with products, inspection and measurement equipment.
• Drive change control processes and activities.
• Participate in CAPA activities as required.
• Initiate CCOs and revise or create documentation for validation activities (Risk Management, MSA, FAI, IQ, OQ, PQ, PPAP, Gage R&R, DOE).
• Collaborate with Supply chain, R&D Engineering, Operations Engineering and Manufacturing to identify variability and implement improvements.
• Evaluate process critical quality parameters and update specifications and protocols.
• Assist in other quality or engineering activities as requested.
• Customer Feedback and Nonconformance Support: Documents and investigates customer feedback and nonconformances; tracks performance metrics; communicates with internal and external customers.

Skills

Analytical skills

Interpersonal skills

Time management

Attention to detail

Communication

Education

Bachelor’s degree in Engineering or Science

Tools

Metrology equipment

Minitab or similar statistics software

CEBOS

Green Light Guru

MasterControl

Qualio

Veeva

Microsoft Office Suite

Job description

Putnam Plastics Corporation (PPC) is seeking a Technical Quality Engineer to apply quality and process engineering principles to investigate, analyze, and optimize processes for ongoing product quality and regulatory compliance. You will participate in continuous improvement and support documentation, validation, and CAPA activities.

The role requires hands-on use of metrology equipment, review of CTQs, and collaboration with supply chain, R&D, and operations to reduce variability and drive