Supplier Quality Engineer II - Audit & CAPA Lead

INA Solution; West Boylston (MA); On-site; USD 85,000 - 120,000; Full time

Job summary

INA Solution in West Boylston, MA seeks a hands-on Quality Engineer II to strengthen supplier quality management within a regulated manufacturing environment. You will own supplier quality issues from detection to resolution and work with suppliers, engineering, and operations to prevent recurrence.

The role emphasizes data-driven root-cause analysis, CAPA, supplier audits, and continuous improvement, with responsibility for MRB support, SCARs, and ensuring adherence to ISO 13485 and cGMP

Qualifications

• Bachelor's degree in Engineering, Science, or related discipline preferred.
• Six or more years in supplier quality engineering or related manufacturing roles.
• Experience with supplier quality management, audits, corrective actions, and supplier development.
• Knowledge of root cause analysis, nonconformance management, and CAPA processes.
• Experience in ISO 13485 environment and cGMP preferred.
• Understanding of SPC and implementation of quality controls.
• Strong analytical, problem solving, organizational, and documentation skills.
• Excellent communication and cross functional collaboration skills.
• Ability to manage multiple issues and ensure timely follow-through.

Responsibilities

• Manage supplier quality issues and drive CAPAs.
• Conduct supplier audits, visits, source inspections, and supplier quality assessments.
• Monitor supplier performance metrics and implement improvement initiatives.
• Lead supplier development including qualification and performance improvement.
• Manage SCARs and ensure timely resolution of quality issues.
• Perform root cause analysis and corrective actions to prevent Recurring defects.
• Coordinate with suppliers, manufacturing, engineering, and internal quality teams.
• Support MRB activities related to supplier defects and nonconforming materials.
• Develop and maintain supplier quality metrics and reporting.

Skills

Supplier quality management

Analytical skills

Cross-functional collaboration

Communication

Problem solving

Documentation

Education

Bachelor's degree in Engineering, Science or related field

Job description

INA Solution in West Boylston, MA seeks a hands-on Quality Engineer II to strengthen supplier quality management within a regulated manufacturing environment. You will own supplier quality issues from detection to resolution and work with suppliers, engineering, and operations to prevent recurrence.

The role emphasizes data-driven root-cause analysis, CAPA, supplier audits, and continuous improvement, with responsibility for MRB support, SCARs, and ensuring adherence to ISO 13485 and cGMP