Mizuho OSI · 15 hours ago
QA Engineer 4
Union City, CA
Full-time
Onsite
Senior Level
$136K/yr - $156K/yr
7+ years expMizuho OSI is the leader in specialty surgery and patient positioning, focusing on improving patient outcomes in surgical procedures. The Quality Assurance (QA) Engineer is responsible for managing quality assurance programs to ensure compliance with regulatory requirements and to support the company's goals and objectives.
BiotechnologyHealth CareManufacturing
Responsibilities
Provide QA Engineering input and guidance during manufacturing, production and design activities in support of new product introductions and modifications to existing products. The support includes but is not limited to the review and approval of validation documentation, test reports, and procedures according to change control requirements
Conduct Internal Audits to ensure compliance with the established procedures and applicable regulatory requirements. Manage all aspects of the audit lifecycle: to include scheduling, planning, issuing agendas, executing, issuing reports, reviewing and approving reports, evaluating responses, requesting clarification, issuing CA/PA and closing out of audits
Maintain and continuously improve the inspection readiness program to ensure the site is always prepared for regulatory and internal audits. Serve as a support during external audits (e.g., Notified Bodies, FDA, Corporate), including logistics, documentation, and auditee coaching)
Manage processing of Complaints and CAPAs. Act as SME for the assigned issues to contain, investigate, develop action plans, and drive to closure as required within prescribed timelines
Monitor and ensure compliance with applicable regulatory standards applicable to Mizuho OSI (QMSR, ISO 13485, ISO 14971, EU MDR, REACH, RoHS, PFAS, etc.). Participate in the development and implementation of quality policies, procedures, and processes aligning with GMPs and applicable regulations. Work closely with multi-functional teams / system owners to lead and/or support continuous improvement initiatives related to QMS improvement. Develop quality data management tools, applicable compliance performance metrics (KPIs) and remediation plans for identified non-conformances
In collaboration with RA, Marketing and Manufacturing teams, manage all aspects of labeling process for registered company products, ensuring accuracy, compliance, and consistency of labeling content throughout product lifecycle. Maintain internal procedures for labeling design, processing, and control to ensure compliance with applicable requirements by regularly reviewing and updating the procedures as necessary
Review and develop documentation for acceptance, monitoring and validations for EO/Gamma/E-Beam sterilization and clean/controlled manufacturing environment
Utilize standard statistical analysis techniques to determine product acceptance: evaluate process capabilities; and develop statistically sound tolerance limits based on product specifications, recommend sampling plans, inspection methods, etc
Responsible for a professional work area to include cleanliness, organization, and overall QA department appearance
To be willing to share knowledge and instruct other members of the department and the company, by passing along skills and information to assist them in their development
To help create an ongoing effort through personal action and by contributing ideas to support both the department and Company’s ongoing improvement efforts
To understand Mizuho OSI’s business objectives and the relationship between the department and those objectives
To understand, follow and support Mizuho OSI’s internal Quality System policies, procedures and work instructions including but not limited to applicable external regulations (FDA’s QMSR, ISO 13485, ISO 14971 and applicable International Standards)
Qualification
Required
Bachelor's degree in science or related field; and 7-10 years of related experience in mechanical or electromechanical medical device manufacturing
Experience with mechanical and electro-mechanical medical device manufacturing
Previous experience with managing quality systems: CAPA, Complaints processing, NCR, MRB, Deviations
Thorough knowledge on ISO standards, FDA's QMSR, EU MDR and other regulations as applicable to Mizuho OSI's products
Familiar with ISO/IEC/IEEE 12207 (Systems and software engineering — Software life cycle processes) and IEC 62304 (life-cycle requirements for the development of medical software and software within medical devices)
Possess Equipment Qualification Experience (IQ/OQ/PQ). Provide assistance and/or perform inspection, and electrical safety testing. Ability to perform basic statistical analysis, calculating C&R, create and reconcile reports, demonstrate strong analytical skills, and attention to detail
Knowledge of sterilization methods for medical devices. Thorough understanding of acceptance, monitoring and validations for EO/Gamma/E-Beam sterilization and clean/controlled manufacturing environment
Demonstrated knowledge of engineering applications, CAD and Solid Modeling software. General understanding of Geometric Dimensioning and Tolerance (GD&T) skills
Ability to work independently and collaboratively with small and cross functional teams
Excellent computer skills including operating Windows based personal computers, various office equipment and machines, and telephone system. Ability to efficiently and effectively use Microsoft products such as Outlook, Word, Excel, Project, Visio and PowerPoint to analyze data, produce trend charts and presentation
Ability to clearly express oneself verbally in the English language (additional languages also preferred) using good grammar, vocabulary, eye contact, and friendly voice inflection with all employees. Ability to communicate effectively with employees and other business contacts in a courteous and professional manner
Ability to clearly and effectively express oneself through written means, to properly use such technical factors as grammar, punctuation, vocabulary, and correct spelling. To be able to prepare business letters, memorandums, and reports. Excellent verbal and written communication skills, strong presentation, project and organizational skills
Excellent customer focus with a high sense of urgency to create positive experiences, and if applicable, resolutions. Ability to provide excellent interpersonal and communication skills
Ability to function calmly in a fast-paced environment managing multiple priorities simultaneously. To be able to positively manage situations of a dynamic nature; to be able to modify plans, actions, and decisions considering changing situations and circumstances while still meeting, or proposing modified, deadlines
To respond sensitively to the needs and feelings of others regardless of position; to accept interpersonal differences, to maintain rapport, and to interact effectively with all levels of employees within the organization
To be able to demonstrate an understanding, and the regular use of a time management process, which systematically structures one's own work to provide for effective task performance and to plan and prioritize items to meet future demands
Ability to establish and accomplish goals independently and to function as a positive and productive team member
Neat and professional appearance and outgoing people-oriented personality which conveys pride in working for Mizuho OSI and which is demonstrated with a ready smile and a willingness to assist others
Preferred
ASQ Certification for CQE, CQA. Auditor certification for ISO 13485 is desirable
Familiarity with “Lean” manufacturing principles is preferred
Benefits
Annual potential bonus
Comprehensive benefits package
Company
Mizuho OSI
Mizuho OSI is a medical devices company offering specialty surgical tables and reusable medical products.
201-500 employees
H1B Sponsorship
Mizuho OSI 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 (6)
2024 (8)
2023 (2)
2022 (8)
2021 (1)
2020 (4)
Funding
Current Stage
Growth StageRecent News
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