Director QA and Engineering Be part of Senior Management

Location: Utrecht region, the Netherlands Job Title: Director Quality Engineering : Product and Process Innovation Reports to: VP QA/RA Direct Reports: Senior and Junior Quality Engineers About the Role This is a rare opportunity to lead the quality function for product and process innovation, development, and transfer in a rapidly scaling medical device company with products already on the market : and multiple new launches scheduled this year.

As Director Quality Engineering, you will set the strategic direction for quality in product and process design, validation, and technology transfer.

Youll ensure compliance with global regulatory standards while driving a culture of excellence and continuous improvement across engineering and manufacturing teams.

This is a highly visible position that requires proven executive stakeholder management : you will regularly engage with senior leadership, regulatory authorities, and strategic partners.

With expansion and scope growth ahead, the role offers a clear pathway toward an executive leadership position.

Key Responsibilities * Define and execute the quality strategy for product, process, and technology development in a regulated environment.

* Lead, inspire, and grow a team of experienced quality engineers and specialists.

* Ensure design, validation, and transfer activities meet ISO 13485, MDR, 21 CFR 820, GMP, and internal QMS requirements.

* Oversee risk management across the full product lifecycle and implement robust quality control strategies.

* Allocate resources strategically and represent quality in senior management and program meetings.

* Anticipate and mitigate risks while ensuring timelines and business objectives are met.

* Represent the company in audits, high:level regulatory discussions, and customer engagements.

* Monitor evolving regulations and adapt processes accordingly.

What You Bring * Engineering degree (mechanical, electrical, biomedical preferred). * 10+ years in medical device QA for product/process/technology development or manufacturing.

* 5+ years leading senior engineering teams.

* Strong technical foundation with the ability to engage in hands:on quality discussions.

* Proven experience managing executive:level stakeholders and influencing strategic decisions.

* Ambition, decisiveness, and the credibility to command respect.

Nice to Have: * Exposure to regulatory affairs.

* Knowledge of microbiology, cleanroom environments, or sterilization processes.

* Experience with software:driven, electromechanical, or disposable device technologies.

Why Join This is not just a job : its a career catalyst.

Youll play a pivotal role in scaling operations, influencing new product launches, and shaping the companys future quality framework.

With strong leadership visibility and tangible growth ahead, its an ideal stepping stone to a future executive role.