Quality Specialist (Temporary)

About the role

This temporary position supports the maintenance and compliance of quality systems across multiple sites. It covers updating QMS documents through the change control process and supporting the ASL management and supplier qualification process.

Key responsibilities

• Maintain practical knowledge of applicable regulatory requirements
• Take part in internal audits and external regulatory inspections
• Train colleagues on documentation and records management requirements
• Keep documentation up to date and available for use
• Support records management between plant sites to ensure compliance with applicable laws and regulations
• Follow safety, health and security rules and company security procedures, and support EHS programmes
• Assist in preparing for internal, customer and external audits
• Perform other duties as assigned and trained

Required profile

• Associate or BS degree in engineering, business administration or equivalent; senior college students may also be considered
• 0-2 years of experience; minimum 6 months of work experience preferred
• English proficiency (verbal and written) mandatory
• Strong interpersonal skills and ability to facilitate collaboration

Required skills

• MS Office suite (Excel, Word, etc.) is mandatory
• Familiarity with ISO 13485 and FDA QSMR preferred
• Statistics proficiency preferred