MedTech QA Engineer – Global Compliance

Ferrosan Medical Devices; Søborg; On-site; DKK 208,000 - 312,000; Full time

Job summary

Ferrosan Medical Devices in Szczecin, Poland, is seeking a Quality Assurance Engineer to ensure the quality and regulatory compliance of medical devices used worldwide.

You will provide quality oversight of manufacturing processes, support product lifecycle and validation activities, and collaborate with cross-functional teams to maintain ISO 13485 compliance and internal standards, ultimately improving patient safety and product quality.

Qualifications

• University degree in Engineering (Quality Engineering, Biomedical Engineering, Chemistry, or related fields).
• Minimum 3 years of experience in a quality-related role within manufacturing; medical device industry preferred.
• Fluent English (oral and written).
• Solid knowledge of ISO 13485, ISO 14971, ISO 14644 and FMEA methodology.

Responsibilities

• Provide quality oversight for manufacturing processes and independent batch release.
• Define and maintain quality standards, in-process controls and acceptance criteria.
• Lead nonconformity management including RCA, CAPA and quality trend analysis.
• Support risk management activities (ISO 14971, FMEA) and process validation (IQ/OQ/PQ).
• Participate in product lifecycle activities including technology transfer and post-market support.
• Train production personnel and participate in audits (internal, customer, and notified bodies).
• Ensure ongoing compliance with ISO 13485 and internal quality system requirements.

Skills

Quality Assurance

Regulatory Compliance

Root Cause Analysis

CAPA

ISO 13485

ISO 14971

FMEA

Education

University degree in Engineering (Quality Engineering, Biomedical Engineering, Chemistry, or related fields)

Tools

CSV

GAMP 5

Job description

Ferrosan Medical Devices in Szczecin, Poland, is seeking a Quality Assurance Engineer to ensure the quality and regulatory compliance of medical devices used worldwide.

You will provide quality oversight of manufacturing processes, support product lifecycle and validation activities, and collaborate with cross-functional teams to maintain ISO 13485 compliance and internal standards, ultimately improving patient safety and product quality.