Over 10 years of experience within the pharmaceutical and medical devices industry
In these years the candidate gained profound experience as Supplier Quality Manager and Quality Engineer in different big and small companies
The candidate offers the full range in Supplier Management and helps companies with the selection, validation, and the auditing of suppliers
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- M.Sc. Chemical Engineering
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Supplier Quality Management, Supplier Selection, Supplier Audits, Quality Engineer, CMO Management, Risk Management, Process Optimization, Design Control, ISO 13485, 21 CFR820, MDR, GMP, Medical Devices & Pharma
Key-Facts
Extract from previous activities
Medical Devices Company, Switzerland
Quality Engineer
Quality Subject Matter Expert for the company’s Products
Driving CMOs Key Process Indicators to determine process effectiveness, identifying areas for improvement, best practices, scrap reduction and supplier quality improvement
Driving CMO to compliance to 21 CFR Part 820 and maintaining compliance to ISO 13485:2016 and EUR MDR
Supplier’s & CMO’s audits and following up on closure of any non-conformances
Supporting Supplier and CMO selection and approval process
Manager secondary and critical suppliers, and CMOs
Design transfer
Reviewer of process validation reports by external subcontract manufacturers
Associate Director deputy by ensuring the conformity of the devices before their release
Draft, review, and approve Quality Agreements
Pharmaceutical Company, Switzerland
Quality Manager
Manager of a multi-disciplinary team of Engineers based in UK
Responsible for setting up a new team (recruitment and on-boarding), training and reviewing their performance (includes Performance Improvement Plans)
Working closely with production line to identify production trending and issues
Overseeing incoming materials and reducing quality and non-quality costs
Review technical drawings of legacy product designs
Identify applicable regulatory requirements, define new or propose improvements to the existing processes, draft or update SOPs / WIs, develop & conduct training on the new / modified processes
Perform audits (Process and System) and follow up on closure of any non-conformances
Medical Devices Company, Switzerland
Supplier Quality Engineer
Assessing and improving manufacturing processes at CMOs and Suppliers
Work closely with production line and ensure all necessary controls are enforced to be compliant with ISO 13485 and FDA QSR requirements
Reviewing device history files, documenting processes and managing all investigations and corrective actions
Undertaking fast and thorough investigations on commplaints to avoid market disruption
Provide regular progress reports and escalate potenntial risks related to Quality System and/or project status to Quality management and stakeholders
Top5 Medical Devices Company, Switzerland
Supplier Quality Engineer
Performing Supplier Process Verification/ Validation
Supplier Quality representative for audits including ANVISA & TÜV SÜD without major/critical observations
Perform ISO 13485 audits and Technical Assessments
Involving on the Supplier Quality strategy and integrate additional SQ metrics on the Quality Management Review
Establishing communication between management and suppliers to address and resolve quality issues. Drive and manage corrective and preventive actions for issues related to quality
Identify applicable regulatory requirements, define new or propose improvements to the existing processes, draft, or update SOPs / WIs, develop and conduct training on the new / modified processes