QM Process Specialist

medmix is a global leader in high-precision delivery devices, with leading positions in the healthcare, consumer, and industrial end-markets. Our dedication to innovation and technological advancement has resulted in over 900 active patents. With 14 production sites worldwide and a team of nearly 2,700 employees, we provide our customers with quality, proximity, and agility. Headquartered in Baar, Switzerland, medmix\’s shares are traded on the SIX Swiss Exchange (SIX: MEDX).

Responsibilities

• Support the implementation of our global QMS and act as an ambassador by delivering training to users.
• Write global policies considering lean and least burdensome principles, applicable laws, standards, and internal requirements, ensuring alignment with responsible site functions prior to roll-out.
• Assist in creating and structuring the global process landscape, gathering feedback, and analyzing improvement needs continuously.
• Coach local process owners in interpreting global process expectations, support with process issues, and review for improvement opportunities.
• Ensure consistent and timely quality KPI reporting at global and BU levels, collecting and reviewing site KPI data for consistency and trends.
• Assist Quality Managers in defining data sources for quality KPI reporting.
• Support cross-site activities in resolving critical business issues related to quality, such as complaints, CAPAs, and audits.
• Act as Business Application Owner for medmix document management system.

Qualifications

• University degree in technical engineering, life sciences, or equivalent specialized training with extended training in quality standards and tools.
• Experience in Quality Management within the Medical Devices field.
• Practical experience with quality tools like complaints, non-conformities, CAPA, and audits, with a basic understanding of quality topics in production environments.
• In-depth knowledge of laws and standards related to Medical Devices (e.g., ISO 13485, MDR, QSR).
• Proficient in implementing and adapting software tools (ERP, MES, CAQ, DMS, Excel) for quality purposes.
• Ability to convey complex relationships clearly to diverse audiences.
• Excellent written and spoken English and German skills (C1 level).
• Flexibility to adapt working hours for collaboration across different time zones.

Additional Information

• Work in a motivated, international team committed to patient needs.
• Flexible hybrid working environment.
• 30 days of vacation.
• Pluxee Card Benefits, company pension plan, performance-related salary, and other social benefits.
• Modern international working environment.

medmix is an equal opportunity employer, committed to workforce diversity.

93% of our employees go above and beyond to deliver results. Do you have the drive to succeed? Join us and boost your career today!

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