Requirements

Required education level
Ad. Federal PET / Fed. PET Diploma, Bachelor, Master
Required experience
Over 5 years
Required language knowledge
English German
Required skills
QA Compliance Medical Devices Switzerland MEDICAL DEVICES SWITZERLAND compliance medical devices switzerland Medical devices Germany Quality Assurance ISO 13485 medical device jobs Auditor CAPA GERMANY Switzerland germany Quality assurance ISO 9001 Quality management System quality assurance Quality Management System Medical Device jobs Design Assurance ISO 14971 nonstop recruitment. COMPLIANCE Compliance specialist

Details

Location
Other countries
Term of employment
Full time
Sector
Medical technology
Professions
Regulatory Affairs Biology / Biotechnology Chemistry Management / Project Managemen... Pharmaceuticals Pharmacy / Drogstore Production Research & Development / Labor...

Description

Senior Quality Engineer * Medical Device / Pharma * German Switzerland * excellent career prospects * competitive salary

NS Consulting are seeking a Senior Quality Engineer and SME for Medical Device/combinational devices work, with responsibility for ensuring new product development activities for all product projects are compliant to FDA / EU MDR / ISO regulations and standards. This means involvement in quality activities throughout the entire product lifecycle from product concept through industrialization and post market support, but with a greater focus on Design Control processes - an exciting role also as it will collaborate with multiple global functions and manufacturing sites.

Day to day tasks will include

  • Assuring that design & development teams including internal and external team members, follow risk management and Design Assurance processes and all design development work meets applicable FDA and ISO QMS requirements (ISO 13485, 21 CFR Part 4, EU MDR).
  • Assist with development and implementation of the quality system, in line with current and future Med Dev / Combinational product regulations
  • Lead Vendor Management activities relevant to medical device development and manufacturing partners, including audits, quality/development agreements, and monitoring vendor performance.
  • Escalate potential risks related to Quality System and/or project status to Quality management and stakeholders.
  • Define/lead Process improvement activities, drafting/updating SOPs and WIs and training accordingly

The successful candidate should have at least 5 years industry experience in Quality, across Medical Device, Pharmaceutical, and ideally combinational products, and with sufficient seniority to advise on combinational device compliance requirements generally and development activities specifically.

English is mandatory, German beneficial

For more information on this exciting opportunity, please contact the Senior Consultant Andrew Boroky on +41 43 50 80 816, and email him your resume in WORD format to aborokya.boroky@nonstopconsulting.com.

KEY WORDS: Quality Assurance, QA, Design Assurance, Design Control, Compliance, Quality Management System, Auditor, Risk management, SOP, Working instruction, Medical Devices, Combinational Devices, Switzerland, ISO 13485, ISO 14971, FDA, 21 CFR Part 4, EU MDR, Medical Device jobs, nonstop recruitment.

NonStop Consulting
Jan 10, 2021

Contact info

NonStop Consulting
Andrew Boroky
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Not available