Danaher Corporation Senior Specialist Post-Market Surveillance and Complaints in Grens, Switzerland
What you’ll do
Receiving, reviewing, and processing customers feedback assigned while using procedures and Good Documentation Practices.
Chair assigned Complaint Handling Unit (CHU) meetings.
Manage a wide spectrum of post-market quality activities including post-market risk assessment and field actions.
Keep your finger on the pulse: prepare, track, monitor and report on monthly metrics and other key data, ensuring compliance with Customer Defect and Tracking resolution process.
Provide expertise and guidance to support the end-to-end complaints process, ensuring complaints are processed thoroughly and in a timely manner in compliance with internal procedures and metrics.
Strategically and proactively develop the relationship with key internal partners and stakeholders, including R&D, manufacturing and Field Service organization.
Support new business acquisitions by ensuring the integration, implementation and adoption of company processes and procedures.
Perform additional duties as assigned, take part in internal and external audits, be the face of post market surveillance and quality at divisional meetings, identify and highlight high priority quality issues to the management team.
This role has excellent long term career progression potential as you grow with the company.
Who you are
Minimum, Bachelor's degree, preferably in a Science or Engineering field.
Minimum 8 years of experience in complaint handling and post-market surveillance activities within Life Science, Medical Device or Biopharma manufacturing environments.
Comprehensive understanding of ISO 9001, ISO 13485, ISO 14971 and GMP requirements, ideally within the cell therapy landscape.
Analytical, problem solving & root-cause analysis skills.
Excellent communication skills (written and oral), fluent in both French & English.
Experienced in interaction with the Field Technical Service teams both locally & globally.
Excellent organizational, presentation, meeting facilitation and technical writing skills
Ability to work and communicate with others in a professional and effective manner, within a cross-functional team-oriented environment.
Experienced in continuous improvement methodologies & tools
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.