Quality & Process Engineer (m/w/d) – Scientific Affairs

This is Your Job Area

As Quality & Process Engineer (m/w/d) in the Scientific Affairs department, you will ensure that our products meet the highest quality and safety standards. Through the development and optimization of central processes, you will significantly contribute to patient safety and compliance with regulatory requirements.

• You develop and are responsible for processes for Sterilisation, Wiederaufbereitung, and Product Packaging
• You present your results confidently at Surveillance Audits and defend our processes with technical expertise
• You take over the Risk Management around sterilization and processing – for our entire product portfolio
• You create and maintain Work Instructions, SOPs, and other quality-relevant documents
• You actively support at CAPAs, Quality Deviations, and bring yourself into the Norm Work
• You coordinate operational Validation Measures within projects and ensure that machines are validated in a timely manner
• You work closely with External Service Providers, R&D, Production, and Regulatory Affairs – interdisciplinary, solution-oriented, and on eye level

This is What You Bring

• Education:
  • You have a completed degree in the field of Biotechnology, Engineering, or a comparable field
• Professional Knowledge:
  • You bring first-hand experience in the medical technology or pharmaceutical industry – ideally in the quality or process area with
  • You have knowledge in quality management, process validation, and project management
  • You are IT-savvy and comfortable using MS Office – especially Word and Excel
  • You bring fluent German skills (C1 level) and very good English skills in writing and speaking
• Soft Skills:
  • You bring a structured, precise working style and a good sense for documentation and regulatory requirements with We are looking forward to getting to know you.

This is What You Can Expect from Us

• Futures Branch: You will receive a fixed-term employment contract for 24 months in the medical technology industry
• Togetherness: Together for patient well-being!
• Onboarding: You start with an intensive and structured onboarding process through experienced team members and our events weLINK and my LINK
• Work-Life-Balance: 37.5 hours per week | 30 days of vacation | time account | mobile work
• Secured Future?!: We will take care of your future, for example, with a company pension plan including an employer's contribution
• Corporate Benefits: Use numerous employee discounts at various cooperation partners
• Mobility: 25% subsidy to the Germany ticket | free parking spaces | covered bicycle parking lot | bike leasing
• No Stress?: Not with us – we will gladly take over the costs of your move with a tax-free moving allowance up to €964
• Payout: Recommendation bonus for newly hired employees
• Movement: Company sports programs | joint sports events

If you feel addressed by this position and are ready to become part of our engaged team, we look forward to getting to know you.

WALDEMAR LINK GmbH & Co. KG
Human Resources
Sandrin Thiel

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