Senior Device Quality Engineer — MedTech & Combination Products

GXP CONSULTING Switzerland; Basel; On-site; CHF 90,000 - 130,000; Full time

Job summary

GXP CONSULTING Switzerland is seeking an experienced quality professional to join our MedTech & Combination Products team in the Basel area. You will act as quality owner for design control activities across development and industrialisation, ensuring compliance with ISO 13485, MDR, and FDA requirements.

In this role you will review DHF deliverables, participate in design reviews as the independent quality reviewer, and ensure proper transfer of design outputs into manufacturing documentation.

Qualifications

• Master’s degree in Engineering, Life Sciences or equivalent.
• 5+ years of device quality experience in GMP/QMS.
• Strong knowledge of ISO 13485, ISO 11608, MDR and FDA design controls.
• Hands-on experience with FMEA, CAPA, change control.
• Fluent English; French or German is an asset.

Responsibilities

• Act as quality owner of design control activities across development and industrialisation, ensuring compliance with 21 CFR 820 / QMSR, 21 CFR Part 4, ISO 13485 and EU MDR Art. 117.
• Review and approve Design History File deliverables, including the design plan, design inputs, specifications, traceability matrix, verification and validation protocols and reports.
• Participate in design reviews as the independent quality reviewer and ensure that phase-gate deliverables are complete and compliant.
• Ensure design outputs are properly transferred into the Device Master Record and manufacturing documentation.

Skills

Device quality

GMP/QMS experience

FMEA & CAPA

Regulatory knowledge (ISO13485, MDR, 5

Education

Master’s degree in Engineering, Life Sciences or equivalent

Job description

GXP CONSULTING Switzerland is seeking an experienced quality professional to join our MedTech & Combination Products team in the Basel area. You will act as quality owner for design control activities across development and industrialisation, ensuring compliance with ISO 13485, MDR, and FDA requirements.

In this role you will review DHF deliverables, participate in design reviews as the independent quality reviewer, and ensure proper transfer of design outputs into manufacturing documentation.