Quality Engineer I

Freudenberg Group • Beverly, MA

21h

About The Position

The Quality Engineer I supports the development, qualification, and manufacturing of products to meet internal and external requirements. The role uses statistical analysis and quality engineering practices to support project teams and product quality. It contributes to validation planning and execution, design reviews, risk management, and quality documentation. The position also supports resolution of quality issues, audits, and measurement system analysis.

Requirements

• Bachelor's or university degree in Engineering, Chemistry, Biology, or a related science or technical field.
• 0–3 years of experience in medical devices or a related regulated industry.
• Knowledge of statistical methods, process control, and quality tools such as Design of Experiments (DOE), Failure Mode and Effects Analysis (FMEA), Control Plan, MSA, and SPC, as well as GD&T and fixturing.
• Demonstrated experience with formal problem-solving methodologies, critical thinking, and deductive skills.
• Understanding of ISO standards, particularly ISO 13485, ISO 14001, and ISO 14971.
• Knowledge of GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements such as 21 CFR 820 in the United States.
• Familiarity with design control processes to ensure design and development, validation, and verification align with intended use and performance criteria.

Responsibilities

• Understand quality system requirements and support product development, qualification, and manufacturing to meet internal and external requirements.
• Use statistical analysis tools to support project teams.
• Support creation of the Master Validation Plan, validation protocols and reports (IQ/OQ/PQ), quality design review deliverables, risk management plans, and other quality-related documentation.
• Assist with and potentially lead support for nonconformances, complaints, CAPAs, and other activities to resolve quality issues.
• Support internal and external audits and ensure quality system compliance.
• Support Measurement System Analysis (MSA), including Gage R&R and test method validations.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level