Quality Engineer II — Med Device NPI & Process Validation

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

Job summary

Freudenberg Medical LLC is seeking a Quality Engineer to support development, qualification, and manufacturing of medical devices. You will apply quality standards, perform MSA, and drive acceptance decisions across cross‑functional teams, including engineering, operations and regulatory.

You will lead design transfer, DQ/IQ/OQ/PQ, risk management (FMEA) and continuous improvement initiatives. The role requires a Bachelor’s in Engineering or related field and 3+ years in a regulated medical

Qualifications

• Bachelor's/University degree in Engineering, Chemistry, Biology, or related science/technical field.
• 3+ years’ experience in Medical Device or a related regulated industry.
• Strong verbal and written communication across cross-functional teams.
• Understanding of statistical methods, process control, audits, and quality tools.

Responsibilities

• Apply quality standards to support development, qualification and manufacturing of products.
• Use statistical tools to analyze data and drive acceptance decisions, improve process capability, and support Lean initiatives.
• Lead MSA and support product acceptance activities.
• Collaborate with engineering, operations, regulatory, customers and suppliers on change related items.
• Create Master Validation Plan, validation protocols and reports (IQ/OQ/PQ) and risk management plans.
• Lead nonconformances, CAPAs, audits, supplier quality activities and internal/external audits.
• Provide guidance to technicians and lead NPI Quality Activities and design transfer (DQ, IQ/OQ/PQ).

Skills

Statistics

DOE

FMEA

SPC

MSA

GD&T

Fixturing

Metrology

Education

Bachelor's degree in Engineering/Science

Tools

Micro-Vu

Keyence

Job description

Freudenberg Medical LLC is seeking a Quality Engineer to support development, qualification, and manufacturing of medical devices. You will apply quality standards, perform MSA, and drive acceptance decisions across cross‑functional teams, including engineering, operations and regulatory.

You will lead design transfer, DQ/IQ/OQ/PQ, risk management (FMEA) and continuous improvement initiatives. The role requires a Bachelor’s in Engineering or related field and 3+ years in a regulated medical