QA Engineer

About Company

Mizuho OSI is the leader in the markets for specialty surgery and patient positioning. The company’s portfolio includes specialty surgical tables for procedure‑specific approaches that improve patient outcomes in spine and orthopedic surgeries along with disposable and reusable surgical patient care products.

The Quality Assurance (QA) Engineer is responsible for all activities involving quality assurance and compliance with applicable regulatory requirements. The position manages quality assurance programs and processes to ensure the quality of product conforms to the established procedures and applicable regulatory requirements. The position utilizes technical expertise on the FDA’s QMSR, ISO 13485, ISO 14971, EU MDR for Class I and Class II medical devices for capital equipment and their accessories.

The QA Engineer position supports Mizuho OSI in achieving established goals and objectives and follows the Corporate Vision, Mission & Values Statements, to maintain the services and quality levels set by Mizuho OSI.

• 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…