RAQA Automation Program Manager
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Overview
Job Description
Job Description:
POSITION SUMMARY
This position is basedon‑siteand requires four days per week in the Brea office to support collaboration and business needs.
The RAQA Automation Program Manager serves as a key enterprise leader responsible for modernizing Regulatory Affairs and Quality Assurance through advanced automation anddata‑drivencapabilities. This role sets the strategic direction for RAQA automation and digital operations, drivinghigh‑impacttransformation initiatives that strengthen compliance, reduce manual burden, and enable scalable,future‑readyprocesses across the RAQA ecosystem.
ESSENTIAL DUTIES & RESPONSIBILITIES
Essential Duties & Responsibilities
Strategic Leadership & Vision
Define and own the multiyear RAQA automation strategy, aligning initiatives with enterprise priorities, regulatory expectations, and operational needs.
Establisha clear visionfor a digitally enabled RAQA function, including intelligent workflows, predictive analytics, and automated compliance capabilities.
Advise RAQA leadership on digital trends, emerging technologies, and opportunities to accelerate efficiency and compliance
Automation &DigitalProgram Ownership
Lead the identification, prioritization, and execution of automationand digitization of Quality Assurance,QualityManagementSystems, andRegulatory Affairs.
Oversee the development and deployment of intelligent document processing, automated data flows, and digital inspection tools.
Ensure all solutions arevalidated, compliant, and seamlessly integrated into the QMS and enterprise systems.
Operational Excellence & Process Redesign
Driveend‑to‑endprocess simplification and standardization through Kaizens,value‑streammapping, and digital workflow redesign.
Champion automation and digital work instructions to modernize QA operations.
Build dashboards, analytics, andreal‑timevisibility tools that elevatedecision‑makingand improve productivity.
Change Leadership & Global Adoption
Lead global change management efforts to ensure successful adoption ofautomation,new digitaltoolsand processes across all RAQA teams.
Develop training, communication, and capability building programs to elevateautomation &digital fluency within the organization.
Partner with regional RAQA leaders to ensure consistent deployment and sustained adoption across global sites.
Regulatory & Compliance Stewardship
Ensure allautomation &digital solutions meet FDA, EU MDR, ISO 13485, and other applicable regulatory requirements.
Collaborate with RAQA to ensureautomation &digitalenabled processesremaintransparent, defensible, and compliant.
Cross-FunctionalInfluence & Collaboration
Partner with Operations, IT, R&D, and Marketing to ensure alignment and integration ofautomation anddigital initiatives.
Represent RAQA on enterprise digital transformation committees, steering groups, and governance bodies.
Influence senior stakeholders through clear communication, strong business cases, anddata-driveninsights.
Job Requirements:
Qualifications
Bachelor’s degree in Engineering, Computer Science, Quality, Regulatory Affairs, or related field; advanced degree preferred.
7+ years of experience inOperations, Quality Assurance, Regulatory Affairs, orAutomation/Digital Transformation within medical devices, diagnostics, or life sciencespreferred
Demonstrated success leading enterprise levelautomation, ordigital transformation programs.
Demonstrated success implementing inspection automation, test automation, or digital QC systems.
Deep understanding of QMS processes, regulatory requirements, and validation of digital/automation tools.
Proven ability to lead global teams, influence senior stakeholders, and drive change in complex environments.
Exceptional communication, strategic thinking, and program management capabilities.
A successful candidate will:
Operate as a strategic architect of RAQA’sautomation &digital future.
Translate complex regulatory and quality challenges into scalableautomation/digital solutions.
Build momentum and alignment across global teams.
Deliver measurable efficiency, compliance, and capability improvements YOY.
Serve as a visible champion for innovation, simplification, and continuous improvement.
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Target 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.
$135,300 - $175,000Operating Company:
CorporateEnvista is a global leader in the dental industry, uniting more than 30 trusted brands—including DEXIS, Kerr, Nobel Biocare, and Ormco—under one mission: partnering with dental professionals to improve patients’ lives. With a heritage of category-defining innovation, our brands have shaped modern dentistry: Nobel Biocare introduced the first dental implant, Ormco is a pioneer in both traditional and digital orthodontics, DEXIS has long been at the forefront of 2D, 3D and intraoral imaging, and Kerr has supported clinicians for over 135 years. Our high-performing culture is underpinned by our CIRCLe Values and the Envista Business System. Guided by these, we deliver a comprehensive portfolio of technologies, consumables, and services that empower clinicians to provide confident, efficient care—today and for the future. Learn more at http://envistaco.com.
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: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.
Envista 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.
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.
