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Lächelnde Mitarbeiterin im Gespräch mit Kollegin im Büro
Lächelnde Mitarbeiterin im Gespräch mit Kollegin im Büro
ID: 125888

Supplier Quality Manager

  • MedTech
  • Asap
  • Supplier Quality Management, Supplier Selection
  • K-Recruiting Schweiz AG
Ansprechpartner:

Julius Strack

+49 89 1890998-614

julius.strack@k-recruiting.com

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

  • 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

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