Quality Engineer

Location: Marlborough, MA Salary: $75,000.00 USD Annually - $99,000.00 USD Annually Description:
Quality Engineer
Job Summary

The Quality Engineer supports product quality and reliability across Systems products by applying established quality engineering principles and practices. This role partners with Engineering, Manufacturing, Supply Chain, and Operations to ensure product quality, process capability, and compliance throughout the product lifecycle.

Working under general supervision, the Quality Engineer contributes to problem-solving, continuous improvement initiatives, and quality system activities. This position focuses on developing technical expertise while delivering measurable improvements in product and process performance.
Essential Duties and Responsibilities
Product Quality and Reliability

• Support the definition and verification of product quality and reliability requirements, including participation in qualification and reliability testing.
• Analyze product performance and quality data to identify trends, recurring issues, and opportunities for improvement.
• Participate in root cause investigations using structured problem-solving methodologies such as 5 Whys, Fishbone Diagrams, and 8D.
• Contribute to initiatives focused on defect reduction, yield improvement, and product reliability enhancement.

Manufacturing and Process Support

• Provide day-to-day quality engineering support to manufacturing operations.
• Assist with the implementation of containment actions, including Stop Ship and Stop Build activities, under guidance.
• Collect, clean, and analyze quality data from manufacturing, test, and field systems, and generate reports and dashboards to support decision-making.
• Support design transfer activities, including the review and update of manufacturing documentation such as work instructions, Device History Records (DHRs), Bills of Materials (BOMs), and manufacturing routers.
• Participate in process validation activities and continuous improvement efforts.

Quality Systems and Compliance

• Support Corrective and Preventive Action (CAPA) activities, including investigations, documentation, and effectiveness verification.
• Assist in maintaining and improving quality system documentation, including procedures, inspection criteria, and quality metrics.
• Ensure compliance with the Quality Management System (QMS) and applicable regulatory and ISO requirements.
• Participate in internal audits and continuous improvement initiatives.

Required Qualifications
Education

• Bachelor's degree in Engineering, Science, or a related technical field.

Experience

• Minimum of 2 years of experience in a manufacturing or quality engineering role within an electromechanical, industrial, or related industry.
• Experience with precision assemblies, optics, or high-reliability products preferred.
• Familiarity with quality tools and methodologies such as Six Sigma and Statistical Process Control (SPC) preferred.

Knowledge, Skills, and Abilities

• Working knowledge of quality engineering principles and statistical analysis methods.
• Ability to analyze data and develop actionable recommendations using tools such as Microsoft Excel or Minitab.
• Familiarity with ISO 9001 or similar quality management systems.
• Strong analytical, troubleshooting, and problem-solving skills with attention to detail.
• Ability to create and maintain clear documentation, including test protocols, reports, procedures, and quality records.
• Strong verbal and written communication skills with the ability to collaborate effectively across multiple functions.

Core Competencies

• Technical and professional development
• Structured problem-solving
• Data-driven decision-making
• Cross-functional collaboration and teamwork
• Continuous improvement mindset
• Attention to detail and execution excellence

Preferred Qualifications

• Experience supporting manufacturing quality and process improvement initiatives.
• Exposure to qualification testing, reliability testing, or validation activities.
• Understanding of corrective and preventive action processes and quality system requirements.
• Knowledge of statistical methods and continuous improvement tools.

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