Quality Engineer II - Medical Devices, NPI & Process

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

Benefits offered by this job

401K match

Diversity & Inclusion

Personal development

Sustainability & social commitment

Corporate events

Job summary

Freudenberg Medical LLC in Beverly, MA is seeking a Quality Engineer II to apply quality standards across development, qualification and manufacturing of medical devices. You will lead analyses, audits and NPI quality activities to ensure regulatory compliance.

Join a global CDMO with strong focus on ISO 13485, GMP and 21 CFR 820, using MSA, FMEA and DOE tools to drive continuous improvement. Expect collaboration across engineering, operations and suppliers in a fast-paced environment.

Qualifications

• Bachelors degree in Engineering, Chemistry, Biology, or related field.
• 3+ years experience in Medical Device or a related regulated industry.
• Strong verbal and written communication across cross-functional teams.
• Knowledge of ISO 13485 and GMP, plus 21 CFR 820 (US).

Responsibilities

• Apply quality standards to support development, qualification and manufacturing of products to meet internal and external requirements.
• Apply statistical tools to analyze data, drive acceptance decisions, improve process capability and support continuous improvement and lean initiatives.
• Lead Measurement System Analysis (MSA) and supporting product acceptance activities.
• Collaborate cross-functionally with engineering, operations, regulatory, customers and suppliers to assess, document and test change items.
• Create Master Validation Plan, validation protocols and reports (IQ/OQ/PQ) and risk management plans.
• Lead resolution of nonconformances, CAPAs, and quality issues for assigned projects.
• Support supplier quality activities, audits, and supplier qualification.
• Participate in internal and external audits and provide guidance to technicians.

Skills

Quality Assurance

Medical Devices

Statistical Methods

DOE

FMEA

ISO 13485

GMP Principles

Audits

MSA

GD&T

Metrology

Education

Bachelors degree in Engineering

Chemistry or related field

Tools

Micro-Vu

Keyence

Job description

Freudenberg Medical LLC in Beverly, MA is seeking a Quality Engineer II to apply quality standards across development, qualification and manufacturing of medical devices. You will lead analyses, audits and NPI quality activities to ensure regulatory compliance.

Join a global CDMO with strong focus on ISO 13485, GMP and 21 CFR 820, using MSA, FMEA and DOE tools to drive continuous improvement. Expect collaboration across engineering, operations and suppliers in a fast-paced environment.