Device Quality Engineer

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

Have you ever dreamed of working for a company that puts people at the heart of its DNA?

Are you ready to make a difference?

Are you excited about collaborating and sharing your expertise with leaders in our industry?

YES? SO ARE WE!

GXP CONSULTING Switzerland is a Swiss company made up of a passionate team of life-science professionals. Since 2014, we have been providing our clients with cutting-edge expertise and support covering the entire product life cycle.

Join a team where your skills will have a real impact on patients’ lives.

GXP Consulting Switzerland is growing its MedTech & Combination Products team. We're looking for experienced professionals to join demanding drug-device development projects (autoinjectors, prefilled syringes) with leading pharma clients in the Basel area.

What You'll Do :

Design Control & Quality Oversight

• 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.

Profile :

• Master’s degree in Engineering, Life Sciences or equivalent.
• 5+ years of experience in device quality within a GMP/QMS environment, ideally on combination products (autoinjectors, prefilled syringes, pen injectors).
• Solid knowledge of ISO 13485, ISO 11608, MDR and FDA design controls / combination product requirements (21 CFR 820 / QMSR, Part 4).
• Hands-on experience with FMEA, change control, investigations and CAPA.
• Ability to bridge pharma and device cultures and to act as a credible quality partner for R&D and manufacturing.
• Fluent English; French or German is an asset.

About us :

• Human-sized company with great colleagues from a large diversity of cultural and professional backgrounds
• We do care about our people, communicate openly and value feedback
• Work as a team where every member is valued and appreciated
• Opportunity to contribute to ambitious projects within an international and multicultural environment that fosters innovation, collaboration, and professional growth.
• Continuous learning and development opportunities via internal or external training and workshops
• Competitive salary package in line with industry practice together with exceptional employment benefits

At GXP Consulting Switzerland everyone contributes to our joint success and grows individually!