Temporary Quality Assurance (QA) Specialist

MedEnvoy is seeking a detail-oriented and proactive Temporary Quality Assurance (QA) Specialist to support our QA Team during a period of increased operational activity. The successful candidate will work closely with the QA Team and cross-functional teams to maintain and improve our Quality Management System (QMS), support quality processes, and assist with audit and regulatory activities.

This role is ideal for an individual with experience in regulated environments, preferably medical devices, in vitro diagnostics (IVDs), healthcare, or other quality-driven industries.

Key Responsibilities

Quality Management System (QMS) Support

• Support the QA Team in maintaining MedEnvoy's Quality Management System.
• Review, update, format, and control Quality System Procedures (QSPs), Work Instructions (WIs), forms, templates, and other quality documentation.
• Assist with document control activities to ensure compliance with applicable quality and regulatory requirements.
• Support continuous improvement initiatives related to quality processes and documentation.

eQMS Administration

• Assist with the administration and maintenance of Greenlight Guru (GG), MedEnvoy's electronic Quality Management System.
• Support document workflows, training assignments, change requests, and user administration activities.
• Help ensure quality records are maintained accurately and in a timely manner.

Quality Event Management

• Assist in the management of:
• Customer feedback and complaints
• Corrective and Preventive Actions (CAPAs)
• Nonconformities
• Deviations and quality investigations
• Support root cause investigations and documentation of findings.
• Track quality events and ensure timely follow-up of assigned actions.

Audit Support

• Assist with the preparation and execution of:
• Internal audits
• ISO certification audits
• Regulatory inspections
• Customer audits
• Support both remote and on-site audit activities.
• Help coordinate audit documentation, evidence collection, responses, and follow-up actions.

Regulatory and Administrative Support

• Provide administrative support for QA and QA/RA projects.
• Assist with maintaining quality and regulatory records and databases.
• Support special projects and other quality-related activities as required.

Continuous Development

• Complete all required training according to the training curriculum defined for the position.
• Maintain awareness of applicable quality and regulatory requirements.
• Participate in continuous improvement initiatives across the organization.

Qualifications

Required

• Bachelor's degree or equivalent experience in Quality Assurance, Life Sciences, Engineering, Healthcare, Regulatory Affairs, or a related field.
• Strong organizational and documentation skills.
• Excellent attention to detail.
• Ability to manage multiple priorities and meet deadlines.
• Proficiency with Microsoft Office applications.
• Strong written and verbal communication skills in English.

Preferred

• Experience working within an ISO 13485-certified environment is preferred.
• Familiarity with medical device and/or IVD regulations.
• Experience supporting audits, CAPAs, nonconformities, and complaint handling processes.
• Knowledge of document control and training management processes.

Competencies

• Quality and compliance mindset
• Strong analytical and problem-solving skills
• Ability to work independently and collaboratively
• Effective stakeholder communication
• Process-oriented and highly organized
• Professional handling of confidential information

What We Offer

• Opportunity to gain experience in a growing international regulatory and quality environment.
• Exposure to medical device and IVD quality systems.
• Collaborative and supportive team environment.
• Meaningful contribution to maintaining compliance and operational excellence.

Job Types: Full-time, Part-time, Temporary
Contract length: 3 months

Pay: €75,00 - €85,00 per hour

Expected hours: No less than 24.0 per week

Application Question(s):

• Do you have knowledge of ISO 13485 and 21 CFR Part 820?

Education:

• Bachelor's (Required)

Experience:

• QA: 2 years (Required)

Language:

• English (Required)

Work Location: In person