Device Quality Engineer

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 Med Tech & 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.

• 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.

• 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.

• 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!