Senior Quality Assurance Specialist

About the role

The Senior Quality Assurance Specialist is responsible for document control and change control in the Yorba Linda site. In addition, they shall provide support for supplier quality assurance (supplier changes, issue quality notifications and SCARs) as well as support internal and external audits.

Responsibilities

• Document Control: Ensure documents are created and maintained according to QMS procedures; review and approve procedures and records; provide support to create procedures and records.
• Change Control: Ensure changes are requested and executed according to QMS procedures; link BOMs, routers, inspection sheets into SAP and ensure they are correct and complete; track status of ECOs and associated documents within the Document Management System (SAP DMS); verify Change Requests prior to approval, including verifying that all required documentation is provided and defined actions are performed.
• Supplier Quality: Support supplier changes documentation and review; issue quality notifications and SCARs to the supplier; organize and host material review boards to decide on product disposition; support/perform supplier audits.
• Audit Support: Support the Senior Quality Assurance Manager in the preparation of internal and external audits (QMS and MAPPS audits); support the Senior Quality Assurance Manager in any follow-up actions resulting from audits (e.g., CAPA); perform additional tasks as requested by the manager.

Qualifications

• 2+ years of related experience in a regulated industry; preferably in MedTech/Pharma.
• ERP experience; SAP is a plus.
• Knowledge of MS Office applications (Word, Excel, Outlook), with 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 detail-oriented in day-to-day job.

Critical Success Factors

• Mastery of Regulatory Compliance: The ability to ensure documentation meets 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, will be challenging. Clear communication is essential to overcome resistance and ensure successful change adoption and action implementation.

$80,600 - $98,500