Senior Quality Assurance Specialist

Senior Quality Assurance Specialist The Senior Quality Assurance Specialist is responsible for document control and change control at the Yorba Linda site, providing support for supplier quality assurance, internal and external audits, and ensuring compliance with QMS and regulatory standards. Key Responsibilities Document Control : Ensure documents are created and maintained according to QMS procedures; review and approve procedures and records; support the creation of procedures and records. Change Control : Confirm changes are requested and executed per QMS procedures; link BOMs, routers, and inspection sheets into SAP; track status of ECOs and associated documents in SAP DMS; verify change requests before approval. Supplier Quality : Support supplier change documentation and review; issue quality notifications and SCARs; organize and host material review boards; conduct supplier audits. Audit Support : Assist the Senior Quality Assurance Manager with preparation of internal and external audits (QMS and MAPPS); support follow‑up actions such as CAPA; perform additional tasks as requested. Qualifications 2+ years of experience in a regulated industry, preferably MedTech/Pharma ERP. Proficient in SAP and MS Office (Word, Excel, Outlook), with extended knowledge of MS Word. Experience with Document Management Systems, record keeping, Good Documentation Practice. Knowledge of ISO 13485 and 21CFR820. Strong administrative, communication, and organizational skills. Fluent in English, accurate and detail‑oriented. Critical Success Factors Regulatory Compliance mastery to ensure audit readiness. Process accuracy and data integrity with error‑free documentation. Proactive problem solving and continuous improvement mindset. Effective collaboration and communication across cross‑functional teams. Key Challenges Navigating evolving regulatory requirements. Managing multiple priorities and high workload without compromising accuracy. Driving stakeholder engagement and alignment for change implementation. Compensation Target Market Salary Range: $80,600 - $98,500 EEO Statement Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available at: . #J-18808-Ljbffr