Senior Quality Assurance Specialist

United States of America, California, Yorba LindaR5026519United States of AmericaQuality and Regulatory AffairsJob descriptionThe Senior Quality Assurance Specialist is responsible for document control and change control in the Yorba Linda site. In addition they shall provide support supplier quality assurance (supplier changes, issue quality notifications and SCARs) as well as support internal and external audits.KEY RESPONSIBILITIES:DOCUMENT CONTROL:Ensure documents are created and maintained according to QMS proceduresReview and approve procedures and recordsProvide support to create procedures and recordsCHANGE CONTROL:Ensure changes are requested and executed according to QMS proceduresLink BOM's, routers, inspection sheets into SAP and ensure they are correct and completeTrack 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 performedSUPPLIER QUALITY:Support supplier changes documentation and reviewIssue quality notifications and SCARs to the supplierOrganize and host material review boards to decide on product dispositionSupport /perform supplier auditsAUDIT: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 (eg. CAPA).Perform additional tasks as requested by the manager.Job requirementsQUALIFICATIONS:2+ years of related experience in a regulated industry; preferably in MedTech/PharmaERP experience; SAP is a plusKnowledge MS Office applications, Word, Excel, OutlookSpecifically extended knowledge of MS WordKnowledge of Document Management Systems / Record keeping / Good Documentation PracticeKnowledge of ISO 13485 and 21 CFR 820.Good administrative and communication skillsGood organizational skillsFluent in speaking and writing English is requiredAccurate and detailed oriented in the day-to-day jobCRITICAL SUCCESS FACTORS:Mastery of Regulatory ComplianceThe ability to ensure documentation meet compliance requirements is essential for audit readiness and risk mitigation.Process Accuracy and Data IntegrityMaintaining 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 ImprovementThe 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 CommunicationCoordinating 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.#LI-RJ1IND123Target Market Salary Range:Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.$72,000.00 - $122,400.00 AnnualOperating Company:Nobel BiocareEnvista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.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: moreNobel BiocareOperating Company:Nobel BiocareLocation:United States of America, California, Yorba LindaDate Posted:July 5 , 2026Req Number:R5026519BenefitsCaring for our employees and their familiesHealth & WellbeingWe offer comprehensive programs designed to support the health and wellbeing of our employees and their families. From medical coverage to wellness resources, we prioritize helping our people thrive both physically and mentally.Retirement & Financial BenefitsWe are committed to supporting our employees’ financial wellbeing—today and in the future. Our competitive compensation and retirement or savings programs are designed to help employees build financial confidence at every stage of their careers.Life & Disability InsuranceWe provide benefits that help protect employees and their loved ones when it matters most. Depending on location, our life and disability programs offer valuable financial security and added peace of mind during unexpected life events.Paid Time OffWe know that time away from work is essential for rest, balance, and personal priorities. Our paid time off, holidays, and leave programs are designed to give employees the flexibility to recharge and take care of what matters most.Learning & Career DevelopmentWe believe in investing in our people. Through learning opportunities, development programs, and career growth pathways, we empower employees to build meaningful careers and continue growing with us.Our hiring processAt Envista, we’re committed to helping you feel confident and prepared every step of the way. Our interview guide will walk you through what to expect, how to showcase your strengths, and how you can make an impact by helping us champion dental professionals and improve lives.1. Application ReviewAfter you apply, our team will review your experience and qualifications. If your background aligns with the role, a recruiter will reach out to discuss the opportunity and next steps.2. InterviewsYou’ll meet with members of the hiring team to learn more about the role and share your experience. Depending on the position, this may include multiple conversations focused on your skills, experience, and how you can make an impact.3. Offer DecisionIf selected, you’ll receive an offer outlining compensation, benefits, and other details. Our team will guide you through the process and answer any questions to help you make an informed decision.4. OnboardingOnce you join, we’ll support your transition with onboarding resources and guidance to help you get started and feel connected from day one. #J-18808-Ljbffr