Connecting to LinkedIn...

W1siziisijiwmtcvmdyvmjmvmdgvmzmvmdevoda2l3byb2ply3r1cy1iyw5uzxiucg5nil0swyjwiiwidgh1bwiilcixodgwedmymcmixv0

Job Information

Senior Quality Assurance (QA) Manager

Information About this Role

Senior Quality Assurance (QA) Manager, Troisdorf, Germany

Role Responsibilities: 

  • Provides RA/QA guidance to Engineering, Manufacturing, Installation and Service teams (responsible for developing, manufacturing, installing and servicing medical devices in compliance with ISO 13485, ISO 14971 and similar standards)
  • Responsible for ensuring Quality System requirements are established and maintained in accordance with applicable government regulations and standards (e.g. ISO 13485, FDA 21 CFR 820 QSR, MDD 93/42/EEC)
  • Acts as Management Representative according to ISO 13485: 2016
  • Manages the overall audit program including internal, supplier and external audit (e.g. FDA)
  • Directly interfaces with auditors and/or Regulatory Authorities
  • Manages the overall CAPA program
  • Provides organizational leadership to QA team, e.g. hires, develops, remunerates and motivates staff
  • Maintains an efficient quality system by using a risk-based approach and sound decision making
  • Supports project managers on optimal use of RA/QA resources within the projects
  • Supports Regulatory Affairs regarding regulatory submissions e.g. 510(k) submissions in the US, CE marking in the EU, etc.
  • Accountable for reporting on the performance of the overall Quality System
  • Coordinates the forum for conducting management review and collects data for review
  • Works as a cross-functional RA/QA interface towards other locations/sites

Skills & Experience Required:  

  • Ideally several years of work experience in medical device design & development, manufacturing and/or medical device quality assurance, including generation of detailed specifications and requirements
  • Experience of regulated industry (e.g. medical device, aerospace, automotive)
  • Experience with software-hardware interfaces including writing and executing test plans related to software-hardware combined products
  • Several years of management experience or supervisory equivalent
  • Ability, competence and confidence to lead & motivate people cross functionally
  • Sound knowledge and working experience of quality management system, standards and government regulations applicable to medical devices (e.g. ISO 13485, 21 CFR 820 QSR, ISO 14971, MDD 93/42/EEC, EU MDR)
  • Fluent English language skills essential: German language skills desirable.