Product Quality Assurance Engineer

This role presents an incredible opportunity to lead in a collaborative and innovative environment, driving growth and excellence in ResMed’s expanding distribution operations. To support ambitious growth and achieve our outstanding customer experience goals, you’ll work on improving and scaling processes both locally and across European distribution networks.
As a key collaborator, you’ll partner with ResMed Operations, Regional Warehouse Teams, and multiple 3PL providers, leveraging your quality expertise and hands-on operational experience to deliver excellence across our sites while ensuring compliance with quality standards.
Ideal for professionals with process development expertise and a background in quality, this role suits either a Process Engineer with experience in manufacturing or distribution within a regulated industry, or a Quality Engineer with a hands-on approach to solution development, eager to advance their skills in a dynamic and growth-oriented space.

A typical day might consist of:

• Starting the Morning at an Operations standup meeting at the distribution warehouse, to be aware of operational issues.
• Be briefed on a Product quality issue by the Manufacturer on a Regulatory Labelling issue and advise on European containment and rework planning.
• Work on process enhancements to the product returns process to reduce delays
• Review quality metrics for ResMed and 3PL operations and quality systems.
• Provide guidance to ResMed Operations Team on process validation for new Pan-European Operations project

Let’s talk about Responsibilities:

Leadership:

• Respond to quality issues impacting Inventory and working with local and remote ResMed teams to manage product issues including local product corrections. 
• Collaborated with 3PL partners to ensure quality expectations and ISO 13485 compliance, serving as the local point of contact while providing clear guidance to 3PL and ResMed QC teams to uphold product standards.

Quality Systems Development:

• Develop and maintain Standard Operating Procedures (SOPs) for Quality-Operations related functions.
• Be part of the team to build out European Quality Management systems for distribution and Contract Manufacturing Scope.
• Support process Risk management

Cross-Functional Collaboration:

• Proactively partner and build relationships with ResMed Operations teams to support the business, promote a quality driven culture and to support and align with the team’s operational goals.
• Collaborate with engineering, production, inventory, supply chain, and other internal teams to align quality objectives with operational goals.
• Act as a key quality liaison between operations and regulatory functions, sharing timely, factual information with managers and stakeholders on progress, risks, and outcomes.
• Build trust and open relationships with stakeholders across organisations to enhance team effectiveness.
• Lead or facilitate process improvement/standardisation initiatives with wide range of teams with broad ranges of experience in formal process development.

Monitoring, Assessing, and Taking Action:

• Conduct audits, inspections, and risk assessments to identify potential quality gaps and implement corrective actions.
• Provide accurate, factual, and timely updates on quality metrics, audit findings, and improvement initiatives.
• Prepare reports for leadership on quality performance, project progress.
• Communicate changes in policies, processes, and quality standards clearly to internal and external stakeholders.

Training and Development:

• Develop and deliver training materials on quality-related activities to ensure consistent adherence to quality standards.
• Conduct training sessions for internal teams on quality control procedures and regulatory compliance.

Strategic Quality Leadership:

• Drive continuous improvement initiatives, reducing waste and enhancing operational efficiency.
• Serve as local point of contact and support for quality, ensuring compliance with ISO 13485.

Let’s talk about Qualifications and Experience:

Education and Experience:

• Tertiary qualifications in Engineering/Science or related discipline
• 3+ years’ experience in a Manufacturing/Distribution environment
• Fluent English language skills 
• Experience working in ISO13485 or ISO 9001 or similar regulated environments

Skills and Abilities:

• Strong knowledge of quality systems, process development
• Ability to analyse complex problems, communicate and integrate requirements
• Experience with process validation within a regulated Quality System environment (IQ, OQ and PQ).

Reasoning Ability:

• Applies analytical thinking to problem-solving and decision-making.
• Anticipates the impact of decisions on the organization and works collaboratively to achieve outcomes.
• Demonstrates the ability to work independently on assigned projects and programs.

Work Environment

• The office is within our major 3PL operations, either in Venray or Roermond. Optional Work from home approx. 1 day per week.
• May require limited travel to other ResMed EU sites.

Ok, so what's next ?

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!

#LI-EU

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!