Reporting into our Head of Operations, Marc Friedli

Your Responsibilities

• Serve as a key liaison between production teams and project leadership, ensuring clear communication and alignment
• Perform technical troubleshooting and coordinate effectively across multiple departments
• Drive optimisation and continuous improvement within cleanroom operations, environmental controls, and aseptic manufacturing processes (including sterile filtration of medicinal products)
• Develop and implement electronic systems for documenting cleanroom interventions (e.g., MES and deviation management systems)
• Apply proven expertise in Process FMEAs to identify and mitigate risks
• Provide guidance and consultation to customers and suppliers, exercising indirect leadership where appropriate
• Demonstrate flexibility to work in cleanroom environments and during shutdown periods to minimise disruption to ongoing production

Your Skills & Experience

• Bachelor or Master’s degree in Engineering (Mechanical, Electrical, Process, Chemical, or equivalent)
• Professional background: 5 years+ experience in technical project execution within GMP and regulated environments (pharmaceutical, biotech, medical devices or life sciences)
• Solid understanding of cGMP, EU Annex 1, and engineering documentation
• Strong experience in budget planning, project timeline planning, and problem solving
• Hands on working experience in GMP environment and authoring technical documents
• Team player who works efficiently and flexibly within interdisciplinary teams
• Decision maker, taking the lead where appropriate and necessary
• Fluency in English and German – written and spoken, German is a must

Benefits

• You will work in the Bern area for an ambitious and dynamic company in the MedTech sector
• You will benefit from flexible working hours in an exciting and versatile field of activity
• You will work in a company with a flat hierarchy and short decision-making processes
• You can expect a pleasant working atmosphere, with uncomplicated and collegial cooperation
• You will benefit from modern and attractive working conditions and development opportunities
• An attractive salary and very good social benefits round off the offer

To apply for this role, see our LinkedIn jobs page.

Reporting into our Head of Quality, Dr. Dirk Hüber

Your Responsibilities

• Lead the development and implementation of Quality Management Systems in accordance with applicable medical device and IVD regulations and standards, including ISO 13485, FDA QMSR (21 CFR Part 820), and ISO 14971
• Independently manage client projects, primarily on-site at customer locations, providing expert support for Quality Management System design, implementation, and maintenance
• Assess, review, optimise, and remediate existing Quality Management Systems to improve compliance, efficiency, and effectiveness
• Analyse quality and compliance challenges and develop practical, risk-based solutions that balance regulatory requirements with business needs
• Serve as a trusted advisor to clients, providing expert guidance and influencing stakeholders through indirect leadership and strong consultancy skills

Your Skills & Experience

• Master’s degree in Engineering, Natural Sciences, Biomedical Engineering, Materials Science, Pharmaceutical Sciences, or a related discipline
• Minimum of 10 years’ experience within the medical device, IVD, pharmaceutical, or another GMP-regulated industry
• At least 10 years of hands-on experience in the implementation, maintenance, and optimisation of Quality Management Systems compliant with ISO 13485 and/or FDA QMSR (21 CFR Part 820)
• Strong knowledge of medical device and IVD regulatory frameworks, quality requirements, and industry best practices
• Excellent analytical and systematic thinking skills, with a process-oriented and risk-based mindset
• Strong ability to work independently and prioritise effectively
• Outstanding documentation, presentation, stakeholder management, and interpersonal communication skills
• Fluency in English is a must, German language skills are highly desirable

Benefits

• Join an ambitious and dynamic consulting company in the Zurich area, specialising in the MedTech sector and known for its collaborative and positive working culture
• Benefit from flexible working arrangements in a diverse range of challenging and rewarding projects
• Work in an environment with a flat hierarchy, short decision-making paths, and a high degree of personal responsibility
• Enjoy a professional, supportive, and collegial atmosphere where teamwork and mutual respect are highly valued
• Take advantage of modern employment conditions, continuous learning opportunities, and professional development
• Receive a competitive compensation package complemented by attractive social benefits

To apply for this role, see our LinkedIn jobs page.