LET’S TALK ABOUT QUALIFICATIONS AND EXPERIENCE:

• Bachelor’s degree in Engineering, Science, or related technical discipline.
• Minimum of 5 years’ experience in Quality Assurance within a regulated distribution or manufacturing environment.
• At least 3 years of experience managing or leading quality professionals in a multi-site or matrixed environment.
• Demonstrated success implementing and sustaining ISO 13485 or equivalent QMS frameworks.
• Experience with regulatory standards including EU MDR, ISO, MDSAP, and GMP.
• Skilled in problem-solving methodologies (e.g., A3, 8D, DMAIC) and data analysis.
• Proven ability to drive change, influence cross-functional stakeholders, and prioritize in a complex environment.
• Excellent written and verbal communication skills; able to clearly present to senior leadership.

Preferred Attributes

• Experience working in global or multi-regional organizations.
• Lean/Six Sigma certification or equivalent continuous improvement training.

Key Competencies

• Strategic thinker with a hands-on execution mindset
• Collaborative leadership style with strong interpersonal skills
• Highly organized with a strong attention to detail
• Passion for continuous improvement and operational excellence
• Resilient, adaptable, and solution-oriented

LET’S TALK ABOUT THE ROLE:

We are seeking an accomplished and forward-thinking Quality Manager to lead quality operations across our EMEA distribution center (DC) network. This role is pivotal in ensuring the implementation, maintenance, and continuous improvement of a robust Quality Management System (QMS) in a multi-site, regulated environment.
Reporting into the global Quality function, the successful candidate will serve as a strategic partner to Operations, Supply Chain, Regulatory, and Corporate Quality teams, fostering a culture of excellence, compliance, and continuous improvement. This leader will be instrumental in ensuring operational alignment with ISO 13485, EU MDR, and other global regulatory requirements.

LET’S TALK ABOUT RESPONSIBILITIES:

• Provide strategic leadership and oversight for quality activities across multiple DCs in the EMEA region.
• Serve as a trusted advisor and partner to DC stakeholders, fostering alignment across functions.
• Champion a proactive, quality-first culture that drives operational excellence and continuous improvement.
• Lead cross-functional initiatives that simplify, standardize, and enhance QMS processes across sites.
• Prioritize and allocate team resources to support business objectives related to quality, delivery, and cost.
• Deliver regular quality performance insights, risk assessments, and strategic updates to senior leadership
• Ensure audit readiness and compliance with ISO 13485, EU MDR, MDSAP, and other applicable standards.
• Oversee and lead investigations and CAPA execution, leveraging structured problem-solving methodologies (A3, 8D, DMAIC)
• Oversee the local execution of non-conformance and on-hold material processes.
• Identify and mitigate systemic quality risks through data-driven trend analysis and root cause investigation.
• Lead and develop a geographically distributed quality team, fostering high performance, accountability, and engagement.
• Promote a collaborative environment, enabling effective interface with global quality, regulatory, and supply chain counterparts.
• Support system integration opportunities that align with broader supply chain initiatives.