RAQA Automation & Digital Transformation Lead, Envista

Job Description:

POSITION SUMMARY

This position is based on‑site and requires four days per week in the Brea office to support collaboration and business needs. The RAQA Automation & Digital Transformation Lead serves as the enterprise leader responsible for modernizing Regulatory Affairs and Quality Assurance through advanced automation, AI, and data driven capabilities. This role sets the strategic direction for RAQA digital enablement, ensuring the organization evolves into a more efficient, predictive, and globally harmonized function. The leader will drive high impact transformation initiatives that strengthen compliance, reduce manual burden, and unlock scalable, future ready processes across the RAQA ecosystem.

ESSENTIAL DUTIES & RESPONSIBILITIES

Strategic Leadership & Vision Define and own the multiyear RAQA digital transformation strategy, aligning automation and AI initiatives with enterprise priorities, regulatory expectations, and operational needs. Establish a clear vision for a digitally enabled RAQA function, including intelligent workflows, predictive analytics, and automated compliance capabilities. Serve as the senior advisor to RAQA leadership on digital trends, emerging technologies, and opportunities to accelerate efficiency and compliance. Automation & AI Program Ownership Lead the identification, prioritization, and execution of automation and AI initiatives across Quality Control, Quality Systems, Regulatory Affairs, PostMarket Surveillance, and Document Control. Oversee the development and deployment of intelligent document processing, automated data flows, AI assisted risk assessments, and digital inspection tools. Ensure all solutions are validated, compliant, and seamlessly integrated into the QMS and enterprise systems. Operational Excellence & Process Redesign Drive end to end process simplification and standardization through Kaizens, value stream mapping, and digital workflow redesign. Champion the transformation of QC operations through automation, digital work instructions, and AI enabled defect detection where appropriate. Build dashboards, analytics, and real time visibility tools that elevate decision making and strengthen audit readiness. Change Leadership & Global Adoption Lead global change management efforts to ensure successful adoption of new digital tools and processes across all RAQA teams. Develop training, communication, and capability building programs to elevate digital fluency within the organization. Partner with regional RAQA leaders to ensure consistent deployment and sustained adoption across global sites. Regulatory & Compliance Stewardship Ensure all digital solutions meet

FDA, EU MDR, ISO

13485, and other applicable regulatory requirements. Oversee documentation, validation, risk assessments, and audit ready evidence for all automation and AI initiatives. Collaborate with RAQA to ensure AI enabled processes remain transparent, defensible, and compliant. CrossFunctional Influence & Collaboration Partner with Operations, IT, R D, and Marketing to ensure alignment and integration of digital initiatives. Represent RAQA on enterprise digital transformation committees, steering groups, and governance bodies. Influence senior stakeholders through clear communication, strong business cases, and datadriven insights.

Job Requirements:

QUALIFICATIONS

Bachelor's degree in Engineering, Computer Science, Quality, Regulatory Affairs, or related field; advanced degree preferred. 7+ years of experience in RAQA, Quality Systems, Regulatory Affairs, Manufacturing or Digital Transformation within medical devices, diagnostics, or life sciences. Demonstrated success leading enterprise level automation, AI/ML, or digital 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.

LEADERSHIP PROFILE A

successful candidate will: Operate as a strategic architect of RAQA's digital future. Translate complex regulatory and quality challenges into scalable 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. #

LI-RJ1 IND123

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. $115,000 - $172,500

Operating Company:

Corporate Envista 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. Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including DEXIS, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care. Envista became an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com.