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 Program Manager serves as a key enterprise leader responsible for modernizing Regulatory Affairs and Quality Assurance through advanced automation and data‑driven capabilities. This role sets the strategic direction for RAQA automation and digital operations, driving high‑impact transformation initiatives that strengthen compliance, reduce manual burden, and enable scalable, future‑ready processes 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.
Establish a clear vision for 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 & Digital Program Ownership
Lead the identification, prioritization, and execution of automation and digitization of Quality Assurance, Quality Management Systems, and Regulatory Affairs.
Oversee the development and deployment of intelligent document processing, automated data flows, 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 automation and digital work instructions to modernize QA operations.
Build dashboards, analytics, and real‑time visibility tools that elevate decision‑making and improve productivity.
Change Leadership & Global Adoption
Lead global change management efforts to ensure successful adoption of automation, new digital tools and processes across all RAQA teams.
Develop training, communication, and capability building programs to elevate automation & 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 automation & digital solutions meet FDA, EU MDR, ISO 13485, and other applicable regulatory requirements.
Collaborate with RAQA to ensure automation & digital enabled processes remain transparent, defensible, and compliant.
Cross-Functional Influence & Collaboration
Partner with Operations, IT, R&D, and Marketing to ensure alignment and integration of automation and digital initiatives.
Represent RAQA on enterprise digital transformation committees, steering groups, and governance bodies.
Influence senior stakeholders through clear communication, strong business cases, and data-driven 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 Operations, Quality Assurance, Regulatory Affairs, or Automation/Digital Transformation within medical devices, diagnostics, or life sciences preferred
Demonstrated success leading enterprise level automation, 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.
A successful candidate will:
Operate as a strategic architect of RAQA’s automation & digital future.
Translate complex regulatory and quality challenges into scalable automation/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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IND123
Operating Company:
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.
Job details
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Benefits
Health & Wellbeing
We 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 Benefits
We 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 Insurance
We 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 Off
We 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 Development
We 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.
At 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 Review
After 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. Interviews
You’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 Decision
If 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. Onboarding
Once you join, we’ll support your transition with onboarding resources and guidance to help you get started and feel connected from day one.
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