Quality Assurance Engineer

Location: Union City, CA, US, 94587 Company Overview 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. 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 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 1-2 years of 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 and IEC 62304. 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. ASQ certification for CQE, CQA and/or auditor certification for ISO 13485 are 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. Salary $78,000-$90,000 DOE + annual potential bonus + comprehensive benefits package. Reasonable Accommodations Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Equal Opportunity Employer Statement Mizuho OSI is an Equal Opportunity Employer and makes business decisions based on job related criteria only. Company policy prohibits unlawful discrimination based on race, color, religious creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition including genetic characteristics, sexual orientation, sexual identity, or any other consideration made unlawful by federal, state or local laws. Background Check Mizuho OSI conducts criminal conviction background checks and drug screening through a third‑party screening vendor which includes searches of address history, criminal convictions, court records, education verification, employment verification and reference checks. In addition, depending on the nature of the position for which you are applying, a motor vehicle driving report, a credit report and/or ID checks in other non‑U.S. countries are also included. Criminal conviction background checks will run after an applicant has received and accepted a conditional offer of employment. After a conditional offer is made and before any background check is performed, applicants will receive background check disclosure and consent forms under state and federal laws, such as the Fair Credit Reporting Act and the Investigative Consumer Reporting Agencies Act. Existence of a criminal record is not an automatic bar to employment. An assessment will be made about whether the conviction has a direct and adverse relationship to the job in question. No job offer will be withdrawn, and no adverse action will be taken against any employee, based on the results of a criminal conviction background check, without an individualized assessment of whether the applicant’s conviction history has direct and adverse relationship with the specific duties of the job in question. Veterans & Service Members Mizuho OSI values the service Veterans and their family members have given to our country and we support the hiring of returning Service Members and military spouses. If you are a Veteran or wounded warrior and would like assistance with the employment process at Mizuho OSI, please contact HR at View phone number on click.appcast.io. Persons with Disabilities If you are a person with a disability or a disabled Veteran and are applying for a job with Mizuho OSI, we would like to ensure your application process goes as smoothly as possible. If you need additional assistance, information or answers to your questions, feel free to contact HR at View phone number on click.appcast.io. #J-18808-Ljbffr Mizuhosi