Director of Quality

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

A PE-backed global MedTech has grown quickly through acquisition, bringing together businesses that each joined with their own way of doing quality. We’re looking for a Director of Quality to unite them under one scalable approach.

This is a newly created role, where you’ll set the quality direction for a Class III medical device portfolio from the start. You’ll join up how the sites work, cut the processes and controls that don’t add value, and strengthen the ones that protect the product as the business scales. The goal is to move quality from reacting to problems to preventing them, and to make it something that helps the business grow rather than slowing it down.

You’ll work alongside a newly built leadership team that is already changing how the business operates, and influence 5 site quality leaders across Europe and the US. The role isn’t tied to one site, so you’ll spend regular time at the manufacturing sites in both regions, shaping how they work together.

What we're looking for:
  • Track record of leading quality improvement or transformation across multiple sites, ideally following acquisitions
  • A business-minded approach to quality, comfortable 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

This is a chance to shape quality in a growing business that has the products, the investment and the leadership support to back real change, rather than inheriting a function that’s already set. You’ll have a clear mandate, a senior seat at the table, and visible impact across sites in Europe and the US.

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