POSITION OVERVIEW

The Quality Assurance 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 QSR, ISO 13485, ISO 14971, EU MDR for Class I and Class II medical devices for capital equipment and their accessories including MICROBIOLOGY/STERILIZATION requirements.

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.

We are looking for you, if you have the ability to:

• Summarize the data to make decisions to ensure safe and effective products
• Work with a dynamic team to shape the future of our business
• Partner with cross functional departments to identify opportunities for improvement

Here is what you will do day-to-day

• Provide QA Engineering input and guidance to Manufacturing Engineering, 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 to 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
• 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
• Track and trend Internal Audits, Complaints, CAPAs, NCRs, QSDs and prepare Quality metrics data for periodic monthly/quarterly review meetings. Incorporate sound risk management principles for the data handling process. Identify compliance risks and escalate any new, unknown risk or hazards for further evaluation and mitigation
• Participate in the development, implementation and maintenance of procedures and templates to assist in the evaluation and auditing of suppliers
• Review and develop documentation for acceptance, monitoring and validations for EO/Gamma/E-Beam product STERILIZATION and CLEAN/CONTROLLED MANUFACTURING ENVIRONMENT.
• Co-Chair Material Review Board (MRB) meetings for review of non-conforming materials. Using sound judgement, and impact analysis, negotiate quality decisions
• 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
• Possess Equipment Qualification Experience (IQ/OQ/PQ)
• Manage all aspects of software development lifecycle for automated systems used for quality data management and related Computer System Validation (CSV) projects. Manage change control activities to ensure systems are maintained in validated state
• Prepare, update and maintain software life-cycle documentation (Requirements Documents, Functional and Design Specifications, Software Protocols (IQ/OQ/PQ), test strategies, test scripts, application migration records, and summary reports)
• Perform risk assessments and impact assessments for new software systems to include classification against applicable regulations
• Develop software inventory and trace matrices, as required. Work with Process Owners to ensure adherence to applicable process requirements
• Assist with Product Recall, CAPA and MRB/NCRs activities
• Assist in external regulatory audits as back room support
• 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 then 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
• Assist in other tasks at the discretion of the department manager, as needed.
• Understand, follow and support Mizuho OSI’s internal Quality System policies, procedures and work instructions including but not limited to applicable external regulations (21 Code of Federal Regulations Part 820 Quality System Regulations, ISO 13485 and applicable International Standards).

MINIMUM QUALIFICATIONS

What you will need to be successful in this role:

• Bachelor’s Degree in Life Science or related field.
• Working knowledge of US FDA QS Regulation and ISO 13485, ISO 14971, EU MDR and applicable international regulations
• Working experience in medical device industry is required
• Be 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)
• 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 SolidWorks Modeling software. General understanding of Geometric Dimensioning and Tolerance (GD&T) skills
• Familiarity with “Lean” manufacturing principles is preferred
• Proficient in Microsoft Office tools like Excel, Word etc. Proficient with pivot tables, charts etc.
• Quality Engineering, ISO 13485 Auditor certifications are desired
• 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.
• 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 in light of changing situations and circumstances while still meeting, or proposing modified, deadlines.
• 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
• Attention to detail and strong interpersonal skills with ability to work cross functionally across organization
• Must be self-motivated individual with the ability to handle, organize and prioritize multiple tasks and able to perform to meet deadlines

What you need to be prepared for:

Duties are performed while sitting at a desk for long periods of time. Required duties include operating a computer, reading, writing and using a telephone. Walking or standing within the office area may be required for the operation of office equipment and for attending meetings. The noise level in the work environment is usually low to moderate.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

NOTE: This job description in no way states or implies that these are the only duties or functions to be performed by the incumbent. Employees will be required to follow any other job-related instructions and to perform any other job-related duties/functions requested by their supervisor.

NOTE: This job description in no way states or implies that these are the only duties or functions to be performed by the incumbent. Employees will be required to follow any other job-related instructions and to perform any other job-related duties/functions requested by their supervisor.

BENEFITS
At Mizuho OSI, we believe better solutions and decisions are born of diversity and are proudly an EEO/AA employer. We offer a comprehensive benefits package that includes: medical, dental, vision, life insurance, 401k with matching, educational assistance and more.

Salary: $106,387 to $132,984