Senior Quality Engineer II - Process & Compliance

Coghlin Companies Inc; Westborough (MA); On-site; USD 85,000 - 110,000; Full time

Job summary

Columbia Tech is seeking a Quality Engineer to lead compliance efforts and ensure products are manufactured to strict standards. You will train staff on workmanship and quality, review device history records for approvals, and support ECN/ECN processing with cross-functional teams to drive effective changes on the production floor.

The role emphasizes root cause analysis, CAPAs, supplier quality support, and continuous improvement activities to enhance overall quality across customer accounts.

Qualifications

• Positive attitude and proactive follow-up are required.
• Superior customer service attitude is essential.
• Excellent teamwork, communication, and interpersonal skills are needed.

Responsibilities

• Lead in ensuring compliant manufacture of outgoing products.
• Train personnel on workmanship and quality standards.
• Support process qualification/validation and new product introduction.
• Develop and execute Quality Plans for customer accounts.
• Review device history records for quality approval.
• Assist in ECO/ECN processing and communicate impacts to production.

Skills

Positive attitude

Superior customer service

Teamwork

Communication

Interpersonal skills

Education

Bachelor’s degree in science or engineering

Tools

MS Word

MS Excel

MS Visio

Job description

Columbia Tech is seeking a Quality Engineer to lead compliance efforts and ensure products are manufactured to strict standards. You will train staff on workmanship and quality, review device history records for approvals, and support ECN/ECN processing with cross-functional teams to drive effective changes on the production floor.

The role emphasizes root cause analysis, CAPAs, supplier quality support, and continuous improvement activities to enhance overall quality across customer accounts.