New · posted Oct 15
Envista · Medical Devices
Sr. Manager, Design Assurance Engineering
- Pomona, CA +1 more
- On-site
- Full-time
- Manager
Open until filled
The role
Position 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.
What you need
- 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.
- 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.
IND123
What you'll do
- 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.
Pay and benefits
$151,700 – $165,000 a year
Employer providedTarget 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.
For Field Sales roles, the salary range listed reflects base pay only and does not include incentive pay opportunities under the applicable sales compensation plan
$151,700 - $165,000
Annual performance bonus
Medical/dental/vision benefits
401K match
Where you'll work
Pomona, CA +1 moreOn-siteOpen in Maps (opens in a new tab)
Also posted for: Brea, CA
More jobs in Pomona, CA +1 moreEqual opportunity, accessibility and legal noticesEnvista's statements, word for word
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.
Physical Demands: Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 3% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Manager roles in California25 roles publishing pay
Manager roles in the US105 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $151,700 | — | $165,000 |
| California (middle half) | $156,000 | $165,500 | $181,000 |
| All US (middle half) | $126,000 | $153,000 | $167,500 |
This role: Envista's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Envista's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 47 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk17
- Collaboration and leadership13
- GMP and compliance10
- Validation and qualification5
- Investigations and CAPA3
- Lab testing and methods2
- Documentation and SOPs2
- Data and digital systems2
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
- FDA and partnersMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program
Company hiring pulse
Envista on Regulatory Jobs
- 7
- Open roles
- 6
- Distinct roles
- 6
- Locations
By discipline
- Regulatory4 57%
- Quality3 43%
By level
- Manager3 43%
- Associate & Specialist3 43%
- Senior & Principal1 14%
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Sr. Manager, Design Assurance Engineering at Envista
Open until filled. $152K–$165K a year, employer provided.