Quality Engineer

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

Job Title: Quality Engineer II – Supplier Quality

Location: West Boylston, MA

Duration: Full-time

Job Summary

We are seeking a motivated and hands‑on Quality Engineer II to support supplier quality management and continuous improvement initiatives within a regulated manufacturing environment. This position serves as a key interface between the company and its suppliers, ensuring that supplied materials and components meet quality requirements and that supplier‑related issues are effectively investigated, resolved, and prevented from recurring.

The ideal candidate demonstrates strong ownership, urgency, follow‑through, and communication skills, with the ability to independently drive quality issues to resolution, collaborate with suppliers and internal teams, and constructively escalte concerns when necessary.

Key Responsibilities

• Manage supplier quality issues, investigate nonconformances, and drive corrective and preventive actions.
• Conduct supplier audits, supplier visits, source inspections, and supplier quality system assessments.
• Monitor supplier performance metrics, identify quality trends, and implement improvement initiatives.
• Lead supplier development activities, including supplier selection, qualification, certification, and performance improvement.
• Manage Supplier Corrective Action Requests (SCARs) and ensure timely resolution of quality issues.
• Perform root cause analysis and implement corrective actions to prevent recurring defects.
• Coordinate with suppliers, manufacturing, engineering, operations, and internal quality teams to resolve quality concerns.
• Support Material Review Board (MRB) activities related to supplier‑caused defects and nonconforming materials.
• Collaborate with suppliers on inspection requirements, quality standards, inspection methodologies, and reporting.
• Support new product introduction and product launch activities by coordinating supplier quality requirements.
• Develop and maintain supplier quality metrics, reports, and performance improvement plans.
• Prepare and maintain quality documentation, including nonconformance reports (NCRs), investigations, corrective actions, rework documentation, and validation‑related records, as applicable.
• Support regulatory compliance, quality system assessments, and internal training activities.
• Take ownership of quality issues from identification through resolution, provide clear status updates, follow up on commitments, and escalte unresolved issues appropriately.
• Identify opportunities for continuous improvement in supplier quality systems, processes, and performance.

Required Qualifications

• Bachelor's degree in Engineering, Science, or a related discipline preferred. Equivalent relevant professional experience may be considered.
• Six or more years of relevant experience preferred in supplier quality engineering, medical device manufacturing, medical subassembly or finished‑device manufacturing, supply chain quality, or engineering involving supplier performance improvement.
• Experience with supplier quality management, supplier audits, corrective actions, and supplier development.
• Knowledge of root cause analysis, nonconformance management, and corrective and preventive action processes.
• Experience in an ISO 13485‑certified environment and current Good Manufacturing Practices (cGMP) preferred.
• Understanding of Statistical Process Control (SPC) and experience implementing SPC or similar quality controls.
• Strong analytical, problem‑solving, organizational, and technical documentation skills.
• Excellent communication, interpersonal, customer service, and cross‑functional collaboration skills.
• Ability to manage multiple issues, prioritize urgent quality concerns, and ensure timely follow‑through.

Preferred Qualifications

• Experience with electro‑mechanical or opto‑mechanical products.
• Familiarity with IPC‑610 and IPC‑620 standards.
• Experience with molded plastics, sheet metal, cables and wire harnesses, PCBs, electronics, and machined components.
• Advanced Microsoft Excel, Word, and Visio skills.
• Ownership and accountability
• Urgency and responsiveness
• Strong follow‑through
• Root cause analysis and problem‑solving
• Clear communication and constructive escalation
• Ability to work effectively in a fast‑paced, dynamic manufacturing environment

Working Environment and Physical Requirements

• May require supplier visits, manufacturing environment interaction, and hands‑on quality activities.
• Ability to stand for prolonged periods and lift up to 30 pounds, as required.
• Must be comfortable collaborating with internal teams and external suppliers.