Engineer, Quality

Title: Engineer, Quality

Location: Westford, MA

Duration: 12 Months

Summary

The Quality Assurance (QA) Engineer is responsible for initiating and maintaining quality assurance activities related to medical devices in compliance with regulatory requirements. This role ensures adherence to FDA Quality System Regulation (QSR), ISO 13485, and other applicable international standards. The QA Engineer will support complaint investigations, failure analysis, and continuous improvement of the quality management system.

Key Responsibilities

Quality Assurance & Inspection

• Develop and implement incoming inspection processes for raw materials and components.
• Document and maintain incoming inspection activities and records.
• Provide in-process quality assurance support, including inspection and documentation review.
• Perform final product acceptance activities to ensure compliance with quality standards.

Sterilization & Validation

• Manage the sterilization process, including validation activities and sterile product loads.
• Ensure compliance with regulatory and internal sterilization procedures.

Nonconformance & Corrective Actions

• Track and document nonconforming materials.
• Lead Material Review Board (MRB) meetings and decision-making processes.
• Manage Corrective and Preventive Actions (CAPA) and quality improvement initiatives.

Supplier Quality Management

• Act as the lead QA representative in interactions with suppliers, contractors, and consultants.
• Ensure components, subassemblies, and contract processing meet required quality standards.

Complaint Handling & Investigation

• Lead complaint investigations on returned products.
• Conduct root cause analysis and failure investigations.

Quality System Management

• Manage aspects of the internal quality management system including:
• Receiving inspection
• Calibration systems
• MRB processes
• Documentation control
• Assist with internal quality audits to ensure compliance with regulatory standards.
• Support quarterly management review meetings.

Metrics & Continuous Improvement

• Establish, monitor, and evaluate quality system metrics.
• Identify opportunities for continuous improvement within the quality management system.

Qualifications

Education

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.

Experience

• 3–5 years of experience in Quality Assurance within the medical device industry preferred.
• Experience with FDA QSR (21 CFR Part 820) and ISO 13485 quality standards.

Skills

• Strong knowledge of quality management systems and regulatory compliance.
• Experience with complaint handling, CAPA, and root cause analysis.
• Familiarity with sterilization validation and inspection processes.
• Strong analytical, documentation, and problem-solving skills.
• Excellent communication and cross-functional collaboration abilities.

Preferred Qualifications

• Certification in Quality Engineering (CQE) or related quality certification.
• Experience with supplier quality management and auditing.

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.