Quality Assurance Manager - EMEA Distribution Network

Quality Assurance Manager – EMEA Distribution Network

Join to apply for the Quality Assurance Manager – EMEA Distribution Network role at Resmed .

We are hiring a Product Quality Assurance Engineer to join our team.

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.

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 standards.
• Oversee investigations and CAPA execution, leveraging structured problem-solving methodologies such as A3, 8D, DMAIC.
• Manage non-conformance and on-hold material processes locally.
• Identify and mitigate systemic quality risks through data analysis and root cause investigations.
• Lead and develop a geographically distributed quality team, fostering high performance, accountability, and engagement.
• Promote collaboration with global quality, regulatory, and supply chain teams.
• Support system integration opportunities aligned with broader supply chain initiatives.

Qualifications and Experience:

• Bachelor’s degree in Engineering, Science, or related technical discipline.
• Minimum of 5 years’ experience in Quality Assurance within regulated distribution or manufacturing environments.
• At least 3 years managing or leading quality professionals in a multi-site or matrixed environment.
• Experience implementing and maintaining ISO 13485 or similar QMS frameworks.
• Knowledge of regulatory standards including EU MDR, ISO, MDSAP, and GMP.
• Skilled in problem-solving methodologies (A3, 8D, DMAIC) and data analysis.
• Proven ability to drive change, influence stakeholders, and prioritize effectively.
• Excellent communication skills, with the ability to present to senior leadership.

Preferred Attributes:

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

Key Competencies:

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

Additional information:

• Employees benefit from a bonus plan dependent on organization level.
• Competitive benefits, referral bonuses, and shareholding programs available.
• Internal career growth within a fast-growing international company.

Next steps: Join us to make a difference in healthcare, develop your career, and be part of an inclusive, innovative culture. Apply now!

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