Applied Medical · 1 day ago
Quality Engineer I/II - Manufacturing
Rancho Santa Margarita, CA
Full-time
Onsite
New Grad, Entry, Mid Level
$72K/yr - $85K/yr
0+ years expApplied Medical is a new generation medical device company committed to innovation and excellence in the healthcare field. The Quality Engineer I/II supports the Quality System by enhancing manufacturing and quality processes for medical devices, ensuring product safety and reliability.
BiotechnologyMedical DeviceHealthcareHealth CareMedical
Responsibilities
Maintain and improve elements of the Quality Management System by identifying opportunities to enhance process efficiency and compliance
Monitor quality metrics and trends and lead the preparation and presentation of insights and recommendations during management reviews
Develop and revise process control documentation, including work instructions, control plans, test methods, and graphical aids
Perform statistical analysis to support product verification, process control, and continuous improvement initiatives
Troubleshoot equipment, process, and product issues and collaborate with engineering teams to implement effective corrective actions
Participate in and assess investigations related to customer complaints, Non‑Conformance Reports, and supplier quality documentation
Provide quality engineering guidance on inspection methods, measurement system analysis, and the use of quality assurance tools
Contribute to product and process development activities, including risk analysis, validation planning, product testing, equipment and process validation, and design transfer to manufacturing
Qualification
Required
Bachelor's degree in engineering, science, or a Science, Technology, Engineering, and Mathematics field, or related education and experience (including BS in mechanical engineering or other engineering disciplines)
Demonstrated ability to multitask, prioritize work, and manage time effectively in a dynamic environment
Strong technical, written, and verbal communication skills with the ability to prepare clear documentation and reports
Knowledgeable in product development, process optimization, risk analysis, continuous improvement, and verification and validation practices
Experienced in statistical process monitoring and data analysis software, including the ability to conduct product testing and apply technical documentation
Proficient in Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook
Up to five years of experience in the medical device or manufacturing industry, including internships, co‑ops, or engineering project experience
Experience using project management tools such as Microsoft Project
Working knowledge of statistics related to verification testing, process control, and statistical analysis software such as Minitab
Understanding of manufacturing quality and risk management standards, including ISO 9001 and ISO/IEC 17025, with the ability to interpret and apply relevant regulations
Preferred
American Society for Quality certifications, including Six Sigma, Certified Quality Auditor, or Certified Quality Engineer
Experience with medical device quality systems, including ISO 13485, quality assurance methodologies, and continuous improvement practices
Knowledge of Lean Six Sigma principles and other process improvement frameworks
Familiarity with root cause analysis methods, Design of Experiments, and advanced statistical techniques
Background in clinical or technical writing supporting regulatory documentation, validation reports, and process development records
Benefits
Comprehensive benefits package.
Training and mentorship opportunities.
On-campus wellness activities.
Education reimbursement program.
401(k) program with discretionary employer match.
Generous vacation accrual and paid holiday schedule.
Company
Applied Medical
As a new generation medical device company, Applied Medical is focused on meeting three fundamental healthcare needs: enhanced clinical outcomes, cost containment and unrestricted choice.
Founded in 1987Rancho Santa Margarita, California, USA
5001-10000 employees
H1B Sponsorship
Applied Medical 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 (37)
2024 (32)
2023 (23)
2022 (34)
2021 (18)
2020 (12)
Funding
Current Stage
Late StageLeadership Team
Samir Tall
Senior VP and CFO
Hany Louis
Chief Accounting Officer
Recent News
2026-02-06
Company data provided by crunchbase