Quality Systems Specialist - ISO

Key Responsibilities:

• Administer document and record control systems, ensuring version control, traceability, timely reviews, and overall compliance.
• Perform and document software tool validations and revalidations, ensuring alignment with relevant standards.
• Support supplier selection and ongoing monitoring, including maintaining relevant documentation and ensuring supplier compliance.
• Monitor regulatory developments (e.g. AI Act, GDPR), assess gaps, and implement required changes in the QMS.
• Draft, revise, and maintain procedures and work instructions based on regulatory or process changes.
• Prepare input for periodic management reviews, including KPIs, audit outcomes, and improvement actions.
• Support internal audits and coordinate evidence collection and follow-up actions.
• Proactively identify and drive opportunities for quality improvement or operational efficiency.

Qualifications:

• 3+ years of hands-on experience in a quality or compliance role within a regulated industry (medical devices, pharma, health tech, etc.).
• Strong working knowledge of at least one management system (e.g. ISO 13485, ISO 27001, or ISO 9001).
• Excellent English communication skills (written and verbal); all documentation and communication is in English.
• Experience with documentation systems, change management, and audit readiness.
• Comfortable working independently and taking initiative in a remote setup.
  

Nice-to-Have Certifications (not required):

• ISO Lead Auditor (9001 / 13485 / 27001)
• Regulatory Affairs Certification (RAC) or similar
• Computer System Validation (CSV) training
  

Key Competencies:

• Excellent written and verbal English communicates clearly and professionally with international clients, both in documentation and direct interactions.
• Strong ownership mindset – proactively identifies tasks, follows through independently, and flags issues without needing micromanagement.
• Regulatory awareness and adaptability – keeps up with evolving standards (e.g., ISO updates, AI Act, MDR/IVDR) and translates them into practical system improvements.
• Clear and concise technical writing – able to draft and revise SOPs, validation reports, and audit evidence to meet compliance requirements.
• Process improvement orientation – continuously looks for ways to streamline or strengthen compliance workflows.
• Effective remote collaboration – comfortable in asynchronous, cross-border work environments and knows when to escalate or ask for input.
• Hands-on tool proficiency – experienced with document control systems (EDMS), QMS platforms, and validation or audit tracking tools.