(Sr.) Director QA – Growing scale up heading into new markets!

Location:

Amsterdam – Noord-Holland, Nederland, Netherlands

Salary:

Negotiable

Type:

Permanent

Main Industry:

Search Health, Nursing & Social Services Jobs

Advertiser:

NonStop Consulting

Job ID:

132000125

Posted On:

14 June 2025

Job Title:

(Sr.)Director Quality Assurance

Reports To:

VP QA/RA

Direct Reports:

Quality Engineers (all levels, PPDT)
*

Risk Management Quality Engineer

Location:

Amsterdam-Utrecht region (hybrid working model)

Purpose of the Role:

As Director Quality Engineering for the PPDT function, you will provide strategic leadership to ensure that product and process development activities meet international regulatory requirements, industry standards, and company objectives. You will foster a culture of quality excellence and continuous improvement across the PPDT team and its cross-functional stakeholders.

Key Responsibilities:

Develop and execute the quality strategy for product and process development, ensuring alignment with international regulations and best practices.
*

Build and maintain a high-performing team by identifying skill gaps, driving development, and hiring or contracting as needed.
*

Ensure all PPDT-reviewed documentation and processes meet internal quality standards and applicable regulations.
*

Set clear objectives for the team aligned with broader quality and company goals.
*

Allocate team resources effectively across projects and represent PPDT at cross-functional PMO meetings.
*

Monitor project milestones and escalate risks proactively to senior management while leading mitigation plans.
*

Oversee the full scope of PPDT activities including:

Design and process development
*

Validation and technology transfer
*

Lifecycle risk management
*

Change control and quality control strategies
*

QMS support (CAPAs, non-conformities, training)

Ensure alignment across departments and act as the escalation point for quality-related matters.
*

Represent the PPDT function during audits (internal, customer, regulatory).
*

Monitor regulatory changes and implement process updates accordingly.

Work Environment:

Hybrid work structure (3 days onsite, 2 days remote)
*

Flexibility to accommodate project demands

Qualifications:

Bachelor’s degree in a technical or scientific field (Master’s or business degree preferred)
*

10+ years of experience in quality assurance within product/process/technology development in a regulated environment, preferably in European or US-based companies
*

Minimum 5 years of leadership or people management experience

Required Skills & Experience:

In-depth understanding of ISO 13485, MDR (EU 2017/745), 21 CFR 820, GMP, and Quality System standards
*

Proven experience in the medical device industry
*

Track record of success in scale-up or high-growth environments
*

Ability to influence without authority and lead through collaboration
*

Strong analytical, strategic thinking, and decision-making skills
*

High integrity, sound judgment, and strong interpersonal skills
*

Fluent in English (written and verbal)

Personal Attributes:

Self-motivated and adaptable to shifting priorities
*

Effective team leader and coach
*

Strong collaborator with the ability to guide teams toward impactful business outcomes

Competencies:

Competencies: Communication, Interpersonal Skills, Attention to Detail, Strategic Thinking, Organization, Problem Solving, People Management, Decision Making

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