Sr. Manager, Design Assurance Engineering

United States of America, California, Pomona | United States of America, California, BreaR5026692United States of AmericaEngineeringJob descriptionPosition Summary: The Sr. Manager, Design Assurance Engineering is a strategic leader responsible for driving product quality, regulatory compliance, and innovation across the full product lifecycle—from new product development through manufacturing and supplier management—for dental electromechanical devices and materials. This role leads Design Assurance and Supplier Quality teams and has global responsibility for advancing quality strategies, harmonizing processes across regions, and driving innovation in quality systems, digital transformation, and continuous improvement. Partners cross-functionally to embed quality into product design, supply chain operations, and business decision-making. Champions the adoption of advanced technologies, including automation, data analytics, and AI-driven quality solutions, to improve efficiency, scalability, and compliance while enabling a proactive, risk-based quality culture worldwide.Essential Duties and Responsibilities:Lead, mentor, and develop Design Assurance and Supplier Quality teams, fostering a high-performance, globally aligned culture.Set strategic direction and objectives aligned with business goals, regulatory expectations, and innovation priorities.Drive a culture of accountability, collaboration, and continuous improvement across global teams.Act as a key member of the quality leadership team, influencing enterprise-level quality strategy.Own and drive global design quality strategy, ensuring consistency and standardization across regions and sites.Lead innovation initiatives in quality engineering, including digital QMS, automation, predictive analytics, and AI-enabled tools.Identify and implement best practices to enhance product quality, operational efficiency, and regulatory compliance worldwide.Serve as a thought leader in advancing next-generation quality methodologies and tools.Oversee quality engineering activities for new product development and design changes, ensuring compliance with design controls (risk management, V&V, FMEA).Serve as quality approver at design reviews and tollgates, ensuring alignment with FDA, ISO 13485, and global regulatory requirements.Provide oversight for design transfer, process validation, and lifecycle management to ensure sustained product performance and compliance.Influence product and process design decisions to meet customer and regulatory expectations.Own the global Supplier Quality Management program, including supplier qualification, auditing, performance monitoring, and development.Drive supplier quality improvements using scorecards, KPIs, and structured improvement initiatives.Lead SCAR processes and ensure timely and effective resolution of supplier issues.Lead complex root cause investigations (e.g., 5 Whys, Fishbone, Fault Tree) and drive effective CAPA implementation with systemic improvements.Ensure adherence to global regulatory requirements (ISO 13485, ISO 14971, FDA 21 CFR 820/QMSR, MDSAP, EU MDR).Support internal and external audits and regulatory inspections, ensuring readiness and compliance.Continuously improve quality systems including CAPA, nonconformance, and risk management processes.Partner with R&D, Manufacturing, Regulatory, and Supply Chain teams globally to integrate quality into all stages of product realization.Serve as the primary quality liaison for design and supplier-related decisions.Enable successful product scale-up and commercialization across global markets.Lead implementation and validation of digital quality systems (e.g., eQMS, eDHR).Promote data-driven decision-making through advanced analytics and reporting.Ensure compliance with data integrity and regulatory requirements in digital solutions.Travel up to 15% domestically and internationally to support global operations.Incidental Duties: The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.Job requirementsQualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. This individual must be able to function in a fast-paced environment, where priorities may change rapidly. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Education and Experience:Bachelor’s degree in Engineering required; Master’s degree preferred.Minimum 10 years of progressive relevant experience in a highly regulated industry (i.e. FDA, ISO) required.Minimum 5 years of leadership experience overseeing direct reports required.Proven global experience in a matrix environment strongly preferred.Experience in medical devices, preferably dental devices or materials strongly preferred.Skills and Abilities:Strong leadership presence with the ability to influence across all organizational levels required.Deep knowledge of FDA regulations (21 CFR 820/QMSR), ISO 13485, design controls, and risk management (ISO 14971) required.Expertise in supplier quality management, including audits, qualification, and SCAR/CAPA processes required.Experience with validation (IQ/OQ/PQ), statistical methods, and continuous improvement (Lean, Six Sigma) required.Strong problem-solving and decision-making skills with a proactive, risk-based mindset required.Proficiency in digital quality systems and emerging technologies (automation, analytics, AI) preferred.Excellent English communication and technical writing skills required.Professional certifications (ASQ CQE, CQA, Six Sigma Black Belt) preferred.Physical Demands: Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.Constantly sits.Frequently uses hands and fingers.Occasionally walks and stands.Occasionally bends and stoops.Occasionally reaches up/down with arms.Occasionally lifts and/or moves up to 5 lbs.#LI-MM1IND123Target 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.$115,800.00 - $208,400.00 AnnualOperating Company:KerrEnvista 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: moreKerrOperating Company:KerrLocation:United States of America, California, Pomona | United States of America, California, BreaDate Posted:July 1 , 2026Req Number:R5026692BenefitsCaring 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 Envista