Quality Engineer II - Medical Device NPI & QA Leader

Freudenberg; Beverly (MA); Hybrid; USD 87,000 - 105,000; Full time

Job summary

Freudenberg Medical LLC in Beverly, MA seeks an experienced quality professional to support development, qualification and manufacturing of medical devices. You will apply quality standards, analyze data with statistical tools, lead MSA activities and collaborate with cross-functional teams.

Responsibilities include creating validation plans, IQ/OQ/PQ protocols and reports, leading CAPA resolution, internal and external audits, and ensuring compliance with ISO 13485 and 21 CFR 820.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Biology, or related science/technical field.
• 3+ years’ experience in Medical Device or related regulated industry.
• Strong verbal and written communication across cross-functional teams.

Responsibilities

• Apply quality standards to support development, qualification and manufacturing of products.
• Lead Measurement System Analysis (MSA) and product acceptance activities.
• Collaborate cross-functionally with engineering, operations, regulatory, customers and suppliers to assess change items.

Skills

Statistical methods

Process control

Quality tools

MSA

GMP/regulatory

Documentation & audits

Cross-functional collaboration

Metrology systems

Education

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

Tools

Micro-Vu

Keyence

Job description

Freudenberg Medical LLC in Beverly, MA seeks an experienced quality professional to support development, qualification and manufacturing of medical devices. You will apply quality standards, analyze data with statistical tools, lead MSA activities and collaborate with cross-functional teams.

Responsibilities include creating validation plans, IQ/OQ/PQ protocols and reports, leading CAPA resolution, internal and external audits, and ensuring compliance with ISO 13485 and 21 CFR 820.