Vacancy · immediate start

Quality Management Engineer (m/f/d)

Do you want to shape quality actively and take responsibility — rather than administer forms? Here, behind every quality management case there is an instrument that will later be needed in an operating theatre. That is what makes the difference.

Full-time Permanent Immediate start 78532 Tuttlingen DIN EN ISO 13485 Experience welcome

What the role is about

Erchinger AG manufactures surgical instruments to its customers' order — for spinal surgery, proctology and general surgery. Because our customers carry the regulatory responsibility for their products, our quality management is not an internal end in itself but part of their evidence. The role is taken correspondingly seriously here.

You work in a small team, with a direct line to production and to the management board. When you assess a deviation, you are not talking to a department but to the person at the machine — usually the same day.

Your responsibilities

  • Handling customer complaints independently — from logging the case through root cause analysis to an agreed corrective action.
  • Assessing internal deviations, together with production and with an eye on what is technically feasible.
  • Qualifications and validations: planning, carrying them out and documenting them.
  • Supporting audits — internal, customer and certification audits.
  • Maintaining the quality management system to DIN EN ISO 13485 and developing it further wherever it snags in day-to-day work.
  • Supporting the quality management representative operationally and taking on your own responsibility in defined areas.

Your profile

  • A completed technical degree — medical engineering, mechanical engineering or similar — or a comparable vocational qualification with further training in quality management.
  • Some professional experience in quality management, ideally in medical technology.
  • Sound knowledge of DIN EN ISO 13485 and/or ISO 9001.
  • Excellent written and spoken German (essential) and good English.
  • An analytical, structured way of working — and the willingness to keep chasing a root cause even when the easy explanation is already on the table.
A note on language

Production, documentation and day-to-day coordination here run in German, and our quality records have to be written in German. Excellent German is therefore a genuine requirement for this role, not a formality — English helps in customer contact, but it does not replace German.

Honestly

This position is not for you if you are looking for a large quality management team with clearly divided responsibilities. It is for you if you fancy helping to shape an area — and are happy to walk out onto the shop floor yourself now and then instead of raising a query by ticket.

What we offer

  • 30 days' annual holiday — not staggered by length of service.
  • Flexible working hours that let you plan appointments and family life.
  • Company pension scheme and capital-forming benefits.
  • Tax-free fuel vouchers — a benefit in kind that reaches you net.
  • Training and development, technical as well as regulatory.
  • Free mineral water, coffee and fruit at work.

On pay

We do not publish a figure here, because it says little without your profile — experience, qualifications and the scope of the role all make a difference. We are happy to tell you the starting range for this position before your first interview, though. Simply ask; that is explicitly fine with us.

How to apply

A CV and your certificates are enough. We are glad to read a covering letter, but it does not decide whether we invite you. If you have questions beforehand, give us a call — and if you are applying while still employed elsewhere, we treat your enquiry confidentially.

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