Quality Engineer with over 20 years of experience in the highly regulated indutries like medical devices, pharma/Biotech
The candidate's main focus is Supplier Quality Management
The candidate has supported big and small MedTec companies and has been responsible for the validation process at suppliers worldwide
Has profound experience in all risk classes (I-III) and furthermore with active and non-active medical devices
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- Diploma Electrical Engineering
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Supplier Quality Engineer, Supplier Change Control Owner, Selection and Validation of suppliers, Process Validation, Audits, CAPA / NCs, Risk Management, Risk Classes I-III, Active & Non-Active Medical Devices, ISO 13485, 21 CFR 820, MDD/MDR, Medical Devices
Key-Facts
Extract from previous activities
Medical Devices Company, Germany
Senior Supplier Quality Engineer
EU MDR integration with Supplier Quality Purchasing Controls
Co-ordination of Global Quality Agreement Periodic Review across multiple BUs and sites
Supplier Audits; Supplier Change Control, Supplier Owned Quality
CAPA Mentoring across three Supplier CAPAs
Top 10 Medical Devices Company, Switzerland
Senior Supplier Validation Engineer
Technical expert for the validation processes at suppliers worldwide
Ensure compliance for the company and its suppliers
Manage technical operational problems
Project planning & execution for process validation remediation actions for all suppliers
Review and approval of Validation Master Plans, Protocols, Summary Reports and other supplier validation documents
Execute qualification & process validation reviews according to the requirements
Execute audits according to ISO 13485 and 21CFR820
Pharmaceutical Company, Switzerland
Supplier Quality Engineer
Supplier Change Control Owner dealing with suppliers across multiple sites and franchises
Complete Supplier Quality Functional Impact Assesments
Support Review and Approval of supplier Process Validation Protocols and Reports
Update of supplier and internal component Acceptance / Inspection Criteria
NCMR Owner for supplier Related NCMRs
Top 10 Medical Devices Company, Germany
(Supplier) Quality Manager
Project Manager for Component Qualification Remediation and Analysis
Develop Supplier Controls Process Map
Definition of supplier related process requirements, e.g. supplier selection and qualification, Component Qualification, Risks, …)
Process Development CAPA Management ISO 13485 and FDA 21CFR Gap Analysis
BioTech Company, Germany
Quality Consultant
Deviation / Non-Conformance Process: Directed efficient and effective corrective and preventative actions for material, equipment, procedural, environmental deviations to determine and reduce root / assignable cause using six sigma problem solving techniques (5 Whys, Fishbone etc)
CAPA Management Review for compliance to FDA QSR and ISO regulatory requirements
Batch Record Review
Medical Devices Company, Austria
Supplier Engineer / Quality Engineer
Worked on investigation and closure of NCRs, CAPA investigations and Supplier/customer quality issues for risk class II products
CAPA focused on manufacturing nonconformances and supplier quality customer complaints
Provided review and improvement of QMS procedures and SOPs
Interface with customers on quality improvement and Supplier Quality
Familiar with 21CFR820, cGMP practices and ISO 13485 requirements