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Lächelnde Mitarbeiterin im Gespräch mit Kollegin im Büro
Lächelnde Mitarbeiterin im Gespräch mit Kollegin im Büro
ID: 066511

Quality Manager

  • Pharma & Biotech
  • Asap
  • Quality Engineering, Risk Management, MDR, PRRC
  • K-Recruiting GmbH
Ansprechpartner:

Julius Strack

+49 89 1890998-614

julius.strack@k-recruiting.com

Overview

Availability
Asap, 5 days/week, on-site & remote
Qualification
Diploma Electrical Engineering
Language Skills
German (native), English (business fluent)
Relevant Expertise
Quality Engineering, Risk Management, MDR, Sterility Assurance, PRRC, KPI Management, Mock-up Audits, Quality Management, Medical Devices

Key-Facts

  • Knowledge in production and process validation for active and non-active medical devices (class I (Is), IIa & IIb, class III), including implants

  • Strong knowledge in designing risk analysis and risk management documentation for technology driven medical products

  • Certified 1st and 2nd party Auditor (Internal Audits & Supplier Audits) ISO 9001 / ISO 13485 & 21CFR820

Extract from previous activities

2021 – 2022

Medical Devices Company, Germany

Quality Management

  • Management of the direct reports of the Quality Engineering department

  • Teamlead Quality in Operation and Release

  • Personnel resources and budget responsibility for the department cost center

  • Leading and monitoring of KPIs in Quality Engineering

  • Remediation of legacy Supplier Quality

  • Internal and Supplier Audits

  • KPI Management

2020 – 2021

Medical Devices Company, Germany

Intermin QM Manager

  • Act as Interim Head of Quality Management

  • Quality Engineering

  • Remediation of legacy CAPA’s and Supplier Quality

  • NC, CAPA and Supplier Quality Transition and general process transitions

  • Internal and Supplier Audits

  • Sterility Assurance

  • MDR readiness

  • CSV Process design and execution

2019 – 2020

Medical Devices Company, Germany

CAPA-Manager

  • CAPA Coordination to ensure traceable content, quality and timeliness

  • Computerized Systems audits

  • Remediation of legacy CAPA’s and Supplier Quality for FDA Readiness

  • FDA Inspection due PMA program

  • MDSAP Audit

  • CAPA and Supplier Quality Transition

  • KPI Management

2018 – 2019

Medical Devices Company, Germany

CAPA Manager

  • CAPA Coordination to ensure delivery in content, quality and time

  • Lead and drive CRB's and Support CAPA Owner / CAPA Project Teams

  • Response Letters to Competent Authorities of Audits & Inspections

  • KPI Management

2017 – 2018

Medical Devices Company, Germany

Quality Auditor

  • Conduction of internal audits according 21 CFR 820; ISO EN 13485:2012; MDD; TGA, RDC 59 (ANVISA), Ordonnance 169 (J-PAL) regulations

  • Writing of internal and reports and creation of relevant documentation

  • Follow up of internal and external audit observation to assure appropriate and timely implementation of Corrective Actions

  • Provide Regulatory Compliance support in all areas of Quality System Elements

  • Documentation review in Quality System relevant areas

  • Quality Engineering

2016 – 2017

Medical Devices Company, Switzerland

Quality Engineering

  • Breakdown & implement global procedures to site specific SOP & WI, based on audit observations by complaints

  • Supplier Quality Engineer for new built SQA themes

  • Act as 1st party process lead auditor to ensure compliance to internal SOP & WI as well to Corporate and company processes and quality directive

  • Act as 2nd party auditor (Supplier Auditor) to Supplier

2015 – 2016

Medical Devices Company, Switzerland

Supplier Validation Engineer

  • Technical expert for the validation processes at suppliers

  • Responsibility to ensure compliance for company and its suppliers

  • Resolve & manage technical operational problems in area of expertise for the supplier

  • Project planning & execution for process validation remediation actions for all suppliers

  • Review and approve of validation master plans, protocols, summary reports and other documentation associated with validations from suppliers

  • Execute qualification & process validation reviews according the requirements

  • Execute audits according ISO 13485 and 21CFR820