Quality Systems: Document Control Specialist (Hybrid)

Stryker Corporation; Belfast; Hybrid; GBP 30,000 - 40,000; Full time

Job summary

A leading medical device company is seeking a Quality Systems Specialist - Document Control in Belfast. The role involves managing and maintaining controlled documents to ensure compliance with FDA regulations and ISO 13485 standards. The ideal candidate will demonstrate strong communication and project management skills, alongside a basic understanding of quality systems and regulatory requirements. This position offers a hybrid working flexibility and involves collaboration with cross-functional teams to ensure timely document approval and audits.

Qualifications

• 0-2 years of experience is preferred.
• Basic understanding of US and International Medical Device Regulations is preferred.
• Basic knowledge of Quality Systems (CAPA, audits, Management Review) is preferred.

Responsibilities

• Administer the company’s document control system.
• Ensure compliance with ISO 13485 and other regulatory standards.
• Manage documents throughout their lifecycle.
• Provide guidance on document management processes.
• Coordinate internal and external audits.

Skills

Communication skills

Project management skills

Interpersonal skills

Analytical skills

Problem-solving skills

Education

Level 6 qualification

Tools

Microsoft Office

MS Project

Adobe Acrobat

Job description

A leading medical device company is seeking a Quality Systems Specialist - Document Control in Belfast. The role involves managing and maintaining controlled documents to ensure compliance with FDA regulations and ISO 13485 standards. The ideal candidate will demonstrate strong communication and project management skills, alongside a basic understanding of quality systems and regulatory requirements. This position offers a hybrid working flexibility and involves collaboration with cross-functional teams to ensure timely document approval and audits.