Senior Quality Assurance Specialist

QUALIFICATIONS:

• 2+ years of related experience in a regulated industry; preferably in MedTech/Pharma
• ERP experience; SAP is a plus
• Knowledge MS Office applications, Word, Excel, Outlook
• Specifically extended knowledge of MS Word
• Knowledge of Document Management Systems / Record keeping / Good Documentation Practice
• Knowledge of ISO 13485 and 21 CFR 820.
• Good administrative and communication skills
• Good organizational skills
• Fluent in speaking and writing English is required
• Accurate and detailed oriented in the day-to-day job

CRITICAL SUCCESS FACTORS:

Mastery of Regulatory Compliance

• The ability to ensure documentation meet compliance requirements is essential for audit readiness and risk mitigation.

Process Accuracy and Data Integrity

• Maintaining precise, revision-controlled records in SAP DMS and other document management systems is vital. Success is defined by error-free documentation, timely updates, and reliable traceability throughout the document control and change control process.

Proactive Problem Solving and Continuous Improvement

• The role requires not only executing defined tasks but also questioning and improving processes. A “can do” and “can learn” attitude supports ongoing optimization and adaptation to evolving business needs.

Effective Collaboration and Communication

• Coordinating with cross-functional teams (Quality, Regulatory, Engineering) and facilitating clear communication ensures smooth change implementation and stakeholder alignment. The ability to support process owners and improvement projects is a key success factor.

KEY CHALLENGES:

Navigating Regulatory and Process Complexity:

• The regulatory landscape is continuously changing, with new standards and emerging interpretations. The administrator must stay current, anticipate changes, and adjust processes accordingly to avoid compliance gaps.

Managing Multiple Priorities and High Workload:

• Handling ECOs, document packages, supplier changes and audit support simultaneously requires strong organizational skills and stress tolerance. Prioritizing tasks without compromising accuracy is a persistent challenge.

Driving Stakeholder Engagement and Alignment:

• Achieving buy-in from diverse stakeholders, especially when document and actions impact multiple departments or require cross-functional cooperation which will be challenging.. Clear communication is essential to overcome resistance and ensure successful change adoption and action implementation.

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