Principal Quality Engineer

Insight Global; Bedford (MA); On-site; USD 140,000 - 185,000; Full time

Job summary

A leading staffing firm is seeking a Quality Engineer to lead product lifecycle quality initiatives in Bedford, Massachusetts. This role requires a bachelor's degree in engineering, 9+ years in medical devices, a strong understanding of regulatory standards, and proficiency in quality management methods. The ideal candidate will drive quality improvements and mentor other engineers. Competitive salary range of $140,000 to $185,000 per year.

Qualifications

• Minimum 9 years of experience in relevant fields.
• Strong foundation in engineering/science principles.
• Proven ability to solve complex issues.

Responsibilities

• Lead quality documentation for products.
• Advise teams on compliance with regulations.
• Guide corrective actions and support audits.

Skills

Engineering/science principles

Technical problem-solving

Regulatory and quality standards knowledge

Quality management methods

Statistical techniques

Risk management documentation

Education

Bachelor’s degree in engineering or science

Tools

Lean methodologies

Six Sigma

Job description

Overview

This position ensures product lifecycle activities—spanning design, development, production, distribution, and service—comply with applicable procedures, standards, and regulations. Acting as a technical leader and mentor, the role provides project or program-level guidance, applies quality tools and risk management principles, and promotes continuous improvement across cross-functional teams. The position also supports audits, leads quality initiatives, and may supervise other Quality Engineers.

Base pay range

$140,000.00/yr - $185,000.00/yr

Key Responsibilities

• Lead and review quality documentation throughout the product lifecycle.
• Advise teams on compliance with regulations, standards, and procedures—including those related to cybersecurity and privacy.
• Ensure product quality and complete documentation before approvals.
• Drive implementation of design controls and product realization requirements.
• Lead or support new product development, design changes, and investigations.
• Apply statistical and quality tools to evaluate results, risk analyses, and validations.
• Guide corrective/preventive actions (CAPAs) and support audit readiness.
• Approve change orders related to product performance, processes, and labeling.
• Mentor Quality Engineers and contribute to training and knowledge sharing.
• Lead cross-functional projects and quality system improvements.

REQUIRED SKILLS AND EXPERIENCE

• Bachelor’s degree (or equivalent) in engineering or science.
• Minimum 9 years of experience in medical devices, pharmaceuticals, diagnostics, or clinical laboratories; or 8 years with an advanced degree.
• Strong foundation in engineering/science principles across R&D, quality control, manufacturing, and design.
• Proven ability to apply technical and engineering problem-solving skills to complex issues.
• Deep knowledge of domestic and international regulatory and quality standards.
• Proficient in quality management methods and statistical techniques (e.g., Lean, Six Sigma).
• Understanding of risk-based approaches to compliance, data analysis, and decision-making.
• Having experience - being a true document owner of risk management documentation
• PFMEAs - owning and changing/updating Risk documentation

NICE TO HAVE SKILLS AND EXPERIENCE

• ASQ Certified Quality Engineer (CQE).
• Lean or Six Sigma certification.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance
• Medical Equipment Manufacturing