Global QMS Systems Engineer: Digital Quality & Compliance

Align Technology; Madrid; On-site; EUR 45,000 - 65,000; Full time

Job summary

Align Technology is seeking a QMS Systems Engineer in Madrid, Spain to enhance its global QMS. The successful candidate will ensure compliance and agility within the quality systems, leading integration efforts and harmonization across regions.

This role requires a Bachelor’s degree and 5-7 years of experience in the medical device industry, particularly with QMS processes and eQMS tools. Strong regulatory knowledge, particularly ISO 13485, is essential.

Qualifications

• 5-7 years of experience in QMS processes and electronic QMS tools in medical devices.
• Solid understanding of regulatory requirements including ISO 13485.
• Experience with CAPA investigations and quality procedures.

Responsibilities

• Design and maintain global QMS processes and system workflows.
• Manage the global electronic QMS platform and conduct system validation.
• Lead assessment and harmonization of QMS processes across regions.

Skills

QMS process development

eQMS platform configuration

root cause analysis

regulatory knowledge (ISO 13485, FDA 21 CFR Part 820)

team collaboration

Microsoft Office proficiency

Education

Bachelor’s degree in Engineering or related field

Tools

Arena PLM

Job description

Align Technology is seeking a QMS Systems Engineer in Madrid, Spain to enhance its global QMS. The successful candidate will ensure compliance and agility within the quality systems, leading integration efforts and harmonization across regions.

This role requires a Bachelor’s degree and 5-7 years of experience in the medical device industry, particularly with QMS processes and eQMS tools. Strong regulatory knowledge, particularly ISO 13485, is essential.