Global Quality Director — Multi-Site MedTech (Class III)

Spencer Rigby Ltd.

Brussel Hoofdstad

On-site

EUR 140,000 - 190,000

Full time

13 days ago

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Job summary

Spencer Rigby Ltd. is seeking a Director of Quality to lead a newly created function for a Class III medical device portfolio. The role requires unifying sites across Europe and the US with a scalable quality approach, enabling proactive quality controls as the business scales.

You will travel internationally, align acquisitions, and drive a business-minded quality strategy. A strong background in multi-site medical devices and regulatory knowledge is essential.

Qualifications

  • Track record of leading quality improvement or transformation across multiple sites, ideally following acquisitions.
  • Business-minded approach to quality, weighing risk against business priorities and keeping the business moving.
  • Strong influencing and change leadership skills, including with stakeholders outside your direct authority.
  • Multi-site experience in a multinational medical device business.
  • Continuous improvement expertise (Lean, Six Sigma or similar), with a focus on product quality and manufacturing controls.
  • Class III or implantable medical device experience strongly preferred, in any therapy area.
  • Working knowledge of EU MDR, FDA 21 CFR 820 / QMSR and ISO 13485.
  • Based in Belgium or the Netherlands, with international travel as required.
  • Ophthalmic/ eye care/ vision MedTech experience.
  • Experience scaling manufacturing from a start-up or R&D environment into commercial production.
  • PE-backed or transformation experience.

Responsibilities

  • Set the quality direction for a Class III medical device portfolio from the start.
  • Unite sites under one scalable quality approach and streamline non-value-adding controls.
  • Drive quality improvement across Europe and the US through a multi-site leadership network.
  • Transform quality from reactive problem-solving to proactive prevention.
  • Spend time at manufacturing sites in both regions to shape collaboration and processes.

Skills

Quality transformation
Change leadership
Influencing stakeholders
Continuous improvement
MedTech experience

Tools

EU MDR knowledge
ISO 13485

Job description

Spencer Rigby Ltd. is seeking a Director of Quality to lead a newly created function for a Class III medical device portfolio. The role requires unifying sites across Europe and the US with a scalable quality approach, enabling proactive quality controls as the business scales.

You will travel internationally, align acquisitions, and drive a business-minded quality strategy. A strong background in multi-site medical devices and regulatory knowledge is essential.

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