Ormco · 14 hours ago
Sr. Quality Engineer
Pomona, CA
Full-time
Onsite
Senior Level
$99K/yr - $149K/yr
5+ years expOrmco is a global leader and innovator of high-quality orthodontic products and solutions. The Sr. Quality Engineer will be responsible for ensuring the highest quality standards in products and processes, working closely with cross-functional teams to develop, implement, and maintain quality assurance protocols that comply with regulatory requirements.
DentalMedical Device
Responsibilities
Actively participates in defining customer requirement, product claims and target markets early in the product development lifecycle
Performs quality engineering reviews of design documentation for compliance with stated requirements
Lead complex technical problems where analysis of situations or data requires an in-depth evaluation of various factors and solve a wide range of difficult problems in creative and effective ways
Develops or participates in establishing requirements for all verification and validation (design and process) activities
Apply state-of-the-art inspection and quality engineering/assurance techniques, procedures, instruments, equipment, theories, principles and concepts to products and processes
Leads development of Risk Management documentation
Leads/participates in data collection, analysis, trending and reporting on non-conformances and investigations to determine root cause, corrective and preventive actions
Mentors junior Quality Engineers as required
Participates in internal and external audits and inspections
Maintains process and software validation plans. Writes validation protocols. Facilitates completion of validation activities, performs data analysis, and writes the validation report
Prepares reports to communicate involvement and results of quality assurance and quality engineering activities
Prepares and presents technical and program information to team members and management
Directs technical and administrative workers engaged in quality assurance activities
Applies statistical analysis of data to evaluate the current process and process changes
Maintains a working knowledge of FDA GMP, ISO 13485 standards and other applicable standards
Documents data obtained during all quality assurance activities, consistent with company policies and procedures
Prepares reports to communicate involvement and results of quality assurance and quality engineering activities
Reviews all purchased products or components and provides input to the decision of whether to accept the product and future purchases from the vendor
Supports Regulatory Affairs with their activities related to submissions and notified body filings
Develop an understanding of Envista Business System (EBS) processes and tools and utilize in the execution of projects (i.e. Problem-Solving Process (PSP) and Visual Project Management (VPM))
Any duties or tasks assigned by Supervisor/Manager
Qualification
Required
Bachelor's degree (B. S.) in Engineering or a related field
5 years of experience in quality engineering within medical device industry
FDA Quality System Regulation Part 820 and ISO 13485 experience
Preferred
Certified Quality Engineer preferred
Master's Degree in related field preferred
Effective interpersonal communication skills and able to interface with cross functional teams
Possess critical thinking skills and able to be assertive & challenge the process in a diplomatic manner
Strong verbal, written, and interpersonal skills (explains difficult or sensitive information; works to build consensus); able to explain technical terminology in layman's terms to product development groups, peers, and senior management
Highly organized with a detail-oriented mindset
Portray flexibility and multi-tasking in a dynamic environment with changing priorities
Adaptable to work with software-based development and automated processes
Communicates significant issues or developments identified during quality assurance activities and provides recommended process improvements to management
Works well in a cross-functional team; will speak up to provide guidance to other team members
Solves complex problems; takes a new perspective on existing solutions; exercises judgement based on the analysis of multiple sources of information
Ability to proactively influences designs to achieve product quality and reliability targets that meet or exceed customer expectations
Strong computers skills demonstrating a firm knowledge of Microsoft Office software (Word, Excel, PowerPoint, Outlook, and Microsoft Project). Able to type 50 WPM
Benefits
Annual performance bonus
Medical/dental/vision benefits
401K match
Company
Ormco
Ormco is a provider of orthodontic supplies and equipment.
1001-5000 employees
H1B Sponsorship
Ormco has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (2)
2023 (5)
2022 (2)
2021 (1)
2020 (2)
Funding
Current Stage
Late StageRecent News
Canada NewsWire
2025-09-12
2025-08-21
Company data provided by crunchbase