Quality Engineer II, Medical Devices | NPI & Compliance

Freudenberg Medical LLC; Beverly (MA); On-site; USD 87,000 - 105,000; Full time

Job summary

Freudenberg Medical LLC seeks a Quality Assurance professional to apply quality standards across development and manufacturing of medical devices. You will lead MSAs, audits, and continuous improvement efforts, collaborating with engineering, operations, regulatory, and suppliers to ensure robust quality documentation and change control.

The role emphasizes leading NPI quality activities, design transfer, and risk management, with a focus on ISO 13485, 21 CFR 820, and GMP compliance in a

Qualifications

• Bachelor's degree in Engineering, Chemistry, Biology, or related field.
• 3+ years' experience in Medical Device or related regulated industry.
• Strong communication and cross-functional collaboration.
• Experience with ISO 13485 and GMP in medical device manufacturing.
• Knowledge of DOE, FMEA, Control Plan, MSA, SPC, GD&T.

Responsibilities

• Apply quality standards to support product development, qualification and manufacturing.
• Use statistical tools to analyze data, drive acceptance decisions, improve process capability.
• Lead MSA and product acceptance activities.
• Collaborate cross-functionally with engineering, operations, regulatory, customers and suppliers on change assessments.
• Create Master Validation Plans, IQ/OQ/PQ protocols and reports; risk management.
• Lead resolution of nonconformances, CAPAs, and quality issue resolution.
• Support supplier quality activities and participate in audits.
• Lead NPI Quality Activities and design transfer, including FMEA and regulatory compliance.

Skills

Statistical methods

Cross-functional collaboration

Quality systems

Problem solving

Documentation

Education

Bachelor's degree in Engineering, Chemistry, Biology, or related field

Tools

Design of Experiments (DOE)

FMEA

Control Plan

MSA

SPC

GD&T

Fixturing

Micro-Vu

Keyence

Job description

Freudenberg Medical LLC seeks a Quality Assurance professional to apply quality standards across development and manufacturing of medical devices. You will lead MSAs, audits, and continuous improvement efforts, collaborating with engineering, operations, regulatory, and suppliers to ensure robust quality documentation and change control.

The role emphasizes leading NPI quality activities, design transfer, and risk management, with a focus on ISO 13485, 21 CFR 820, and GMP compliance in a