Stevanato Group · 1 day ago
Quality Engineer
Ontario, CA
Full-time
Onsite
Senior Level
$100K/yr - $140K/yr
5+ years expStevanato Group is a company focused on quality in the development and manufacturing of medical devices. The Quality Engineer will support all aspects of the Quality Management System and collaborate with cross-functional partners to ensure compliance with regulations and continuous improvement in quality metrics.
Health CareManufacturingPharmaceutical
Hiring Manager
Edgar R.
Responsibilities
Support the development and manufacturing of medical devices in conformance with applicable ISO 13485 requirements. Responsible for quality planning of all new development programs and design transfers to production
Ensure policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control
Interact and form constructive working relationships with all levels of leadership within Quality, Procurement, Marketing, Engineering, and Operations
Collaborate with Program Managers, Process Engineers, and/or Validation Engineers to execute process and equipment qualifications
Problem Resolution: identification, data collection and trend analysis, reporting, and initiation of corrective and/or preventive action as well as reporting out of Key Metrics
Identify opportunities and implement solutions to drive continuous improvement in performance metrics
Investigate customer complaints, corrective actions and trending to drive improvements
Plan and perform regular audits of quality system and drive system improvements through the Internal Audit and Quality Event Management (CAPA, NCR, Complaint etc.)
Monitoring and improvement of SPC systems, sampling plans and statistical methods
Back-up and or perform to Head of Site Quality/Supervisor Representative, as assigned
Plan, prepare, and execute Internal Audits, as assigned
Participate in Material Review Board and/or Change Control Board as QA representative
Utilize tools, gauges and other inspection equipment to obtain product specification data
Expert in utilizing hand measurement tools (Caliper, Micrometer, Ruler, Gage Blocks, height gage, etc.)
High Proficiency with PCDMIS inspection software utilizing CMM’s: Brown, Sharpe, Hexagon, Smart scope
Expert with utilizing ANSI Sampling Plans, IQMS, Minitab, Excel and Microsoft Word
High Proficiency in material analysis (i.e. FTIR, Melt Flow Testing, etc.)
Ability to read and decipher blueprints
Proficient in metrology and calibration
Working knowledge of statistical methods for manufacturing
Proficient in Geometric Dimensioning and Tolerancing (ANSI Y-14.5)
Qualification
Required
Minimum Education: five (5) years' experience in a similar field
Working knowledge in problem solving methodologies
Excellent oral and written communication skills
Minimum Experience: At least two (2) year experience in a supervision and/or management role
Demonstrated experience to lead teams and projects
Good organizational skills
Previous experience in plastic injection molding related environment
Working in a medical device or other FDA regulated industry
Comprehensive understanding of ISO 9001, ISO 13485, JPAL MHLW Ordinance 169, and/or FDA QSR regulatory requirements
Computer literate with working knowledge of MS Word, Excel, and Access
A working knowledge of FDA cGMP, ISO13485 requirements
A working knowledge of medical device manufacturing quality systems
Working knowledge of Statistical Methods used in manufacturing
3-7 Years in Quality Engineering in manufacturing and/or quality assurance
Training in applicable ISO 9001, ISO 13485
Experience using Minitab
Proficient in metrology and calibration standards
Proficient in Quality Audit concepts
Preferred
Desired candidate will have prior work history in MSA, SPC, Mini-tab, Infinity, sterilization, & clean room environment
PC-DMIS knowledge a plus
FDA quality standards experience a plus
Certifications such as ASQ CQE, CQA, CQM
Company
Stevanato Group
Founded in 1949, Stevanato Group is one of the world's largest providers of integrated containment and delivery solutions for the biopharmaceutical industry.
5001-10000 employees
H1B Sponsorship
Stevanato Group 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 (1)
2024 (2)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$796.75MKey Investors
BNL BNP ParibasBiomedical Advanced Research and Development Authority (BARDA)
2025-07-23Post Ipo Debt· $234.61M
2024-03-21Post Ipo Equity· $330M
2023-03-08Post Ipo Debt· $137.14M
Recent News
2025-11-07
2025-11-07
2025-11-01
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