Senior Quality Engineer – Medical Devices

Coghlin Companies; Westborough (MA); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

401(k)

401(k) matching

Health insurance

Opportunity for advancement

Paid time off

Profit sharing

Dental insurance

Job summary

Columbia Tech is hiring a Quality Engineer to ensure best-in-class quality for products and to facilitate seamless communication between project teams and customers. The role focuses on compliance, ECN/ECO processing, and CAPA-driven improvements across manufacturing and suppliers.

Ideal candidates have ISO-13485 experience, CQE preferred, and strong problem-solving skills to drive robust corrective actions and data-driven quality metrics.

Qualifications

• Positive attitude, self-motivator, and tenacious follow up required.
• Superior customer service attitude.
• Excellent teamwork, communication, and interpersonal skills.
• Bachelor’s degree, preferably in a science or engineering discipline. Significant and applicable professional experience may be considered in lieu of certain educational requirements.
• Strong electro‑mechanical orientation.
• Experience in ISO-13485 certified required and cGMP organizations preferred.
• 5 years professional experience in medical subassembly and finished device manufacturing required. 6 to 10 years preferred.
• Certified Quality Engineer (CQE) preferred.
• Proven problem solver.
• Knowledge of IPC 610 and 620 standards required. Certified training beneficial.
• Advanced Level Skills in MS Word and Excel such as keyboard shortcuts, creating macros and forms, table techniques, working with images and text, pivot tables.
• Advanced Level Skills in MS Visio such as creating Visio diagrams, creating custom styles and templates, cross functional flowcharts, linking drawings to other MS applications, working with data, custom reports, and exporting is valuable.

Responsibilities

• Promote strict compliance adherence and lead by example.
• Train personnel including customers and suppliers on workmanship and quality standards.
• Ensure all outgoing product is manufactured in a compliant manner.
• Support process qualification/validation and new product introduction processes.
• Develop and execute Control Plans.
• Review device history records for quality approval as needed.
• Oversee ECO/ECN processing and related changes.
• Collaborate with PMs to analyze customer ECNs and implement on production floor.
• Suggest improvements to ECN/ECO processes for efficiency and quality.
• Meet or exceed ECO implementation performance metrics.
• Analyze non-conformances and drive CAPAs with root-cause analysis.
• Collaborate to determine root causes of customer issues and complaints.
• Lead the Quality Control inspection process.
• Develop skills as a trainer for QC inspection resources.
• Develop quality and inspection plans.
• Assist in supplier audit plans under Quality Manager guidance.
• Support supplier quality improvements through data collection and statistics.
• Present quality metrics to customers and suppliers to meet expectations.
• Respond to manufacturing floor quality issues and take action per Quality System.
• Work with Manufacturing Engineers to identify trends and implement corrective actions.
• Collaborate with PMs on optimal work order routings and MRB processes.
• Additional duties as assigned.

Skills

Positive attitude

Customer service

Teamwork

Communication

Interpersonal skills

Problem solving

Education

Bachelor's degree in science or engineering

CQE certification preferred

ISO-13485 knowledge

Tools

MS Word & Excel advanced

MS Visio advanced

IPC 610/620 knowledge

Job description

Columbia Tech is hiring a Quality Engineer to ensure best-in-class quality for products and to facilitate seamless communication between project teams and customers. The role focuses on compliance, ECN/ECO processing, and CAPA-driven improvements across manufacturing and suppliers.

Ideal candidates have ISO-13485 experience, CQE preferred, and strong problem-solving skills to drive robust corrective actions and data-driven quality metrics.