Quality Assurance Engineer

Job Summary: 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.

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).

Qualifications & Requirements: Bachelor's degree in science or related field; and 8-12 years of related experience in mechanical or electromechanical medical device manufacturing or Master's degree and 6+ years or PhD Degree and 3+ years. 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 environmentASQ Certification for CQE, CQA. Auditor certification for ISO 13485 is desirable. Demonstrated knowledge of engineering applications, CAD and Solid Modeling software. General understanding of Geometric Dimensioning and Tolerance (GD&T) skills. Familiarity with "Lean" manufacturing principles is preferred. 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. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Salary range: $136,000- $156,000 DOE + annual potential bonus + comprehensive benefits package