Quality Systems Engineer

Role overview

Work model

• Hybrid work model requiring employees to be in the local office at least three days per week.

Responsibilities

• Maintain and continuously improve the Quality Management System, ensuring compliance with internal procedures and applicable regulations.
• Manage and improve document control processes for accuracy, consistency, and compliance.
• Act as a quality systems subject matter expert and support internal and external audits.
• Identify compliance risks, solve complex quality challenges, and drive practical improvements.
• Partner with cross-functional teams to strengthen quality processes and promote continuous improvement.
• Provide guidance on quality standards and regulatory requirements to support product quality and patient safety.

Required qualifications

• Experience working with quality management systems in a regulated environment.
• Strong knowledge of quality assurance, document control, and regulatory compliance.
• Experience supporting quality system processes, audits, or continuous improvement activities.
• Strong analytical, problem-solving, and communication skills.
• Ability to work independently, take ownership, and collaborate effectively across teams.

Preferred qualifications

• Medical device industry or other highly regulated environment experience is preferred.
• Familiarity with ISO 13485, FDA requirements, and European medical device regulations is preferred.
• Experience with electronic document management systems and quality improvement initiatives is preferred.
• Experience in a distribution, logistics, or supply chain environment is preferred.

Sponsorship and relocation

• Visa sponsorship and relocation assistance are not available for this position.