Quality Engineer I - Process & Compliance Champion

Coghlin Companies; West Boylston (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

Cogmedix is seeking a Quality Engineer I to support compliance across the organization. You will lead quality initiatives, develop training on workmanship standards, and ensure products are manufactured to strict quality control.

Responsibilities include supporting process validation, control plan development, and review of device history records. Strong knowledge of ISO-13485 and cGMP is valued, along with cross-functional collaboration.

Qualifications

• Bachelor’s degree in science or engineering preferred.
• Experience with ISO-13485 and cGMP environments.
• Strong documentation and record-keeping skills.
• Experience with corrective and preventive actions (CAPA).
• Training or mentoring personnel on quality standards.

Responsibilities

• Lead by example to promote compliance across Cogmedix.
• Provide training on workmanship and quality standards to personnel and customers.
• Ensure outgoing product is manufactured in a compliant manner.
• Support process qualification, validation and new product introductions.
• Develop and execute control plans and quality metrics (FPY, nonconformances, ORB trends).
• Review device history records for quality approval as needed.

Skills

Quality assurance

Documentation

Root cause analysis

Training

Education

Bachelor degree in science or engineering

Tools

MS Word

MS Excel

MS Visio

Job description

Cogmedix is seeking a Quality Engineer I to support compliance across the organization. You will lead quality initiatives, develop training on workmanship standards, and ensure products are manufactured to strict quality control.

Responsibilities include supporting process validation, control plan development, and review of device history records. Strong knowledge of ISO-13485 and cGMP is valued, along with cross-functional collaboration.