Manufacturing Compliance 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.

Job Summary

The Manufacturing Compliance Engineer is responsible for all activities within Manufacturing Engineering involving product Configuration Management and tracking activities associated with Mizuho’s New Product Introduction (NPI). Compliance activities include leading Manufacturing Engineering’s conformance to processes broadly relating to regulatory requirements such as ROHS, Reach, PFAS, etc.

Responsibilities:

• Own the tracking of product configurations during NPI activities. Create and manage the configuration record set for all pre-production build activities, also known as Production Equivalent Devices (PED).
• Support includes but is not limited to auditing of routings, validating revision correctness, and creation of configuration records.
•  Support implementation of Engineering Change Orders (ECOs) into pre-production device builds while maintaining proper control and record keeping.
• Prepare, update and maintain hardware life-cycle documentation.
• Execution of projects associated with regulatory compliance in concert with the Regulatory Department.
• Improvement of Manufacturing Engineering’s process efficiencies relating to processes based on current and changing regulatory requirements.
• Implement identified compliance risks to prevent fines, recalls, or legal issues.
• Coordinate and manage product testing activities, document results, and follow up on corrective actions.
• Maintain and organize compliance-related documentation, prepare reports, and manage product certifications.
• Provide guidance, training, and answers to employees about compliance policies and procedures. 
• Write or update standard operating procedures, work instructions, or policies.

• Domestic travel, as needed, to support supplier audits and other business needs, as necessary.

• Train and instruct other members of the department and the company by passing along skills and information to assist in their development and advancement either with one-on-one or with platform training skills.
• Be an independent employee able to analyze problems and formulate plans to overcome challenges and to get work done quickly with a high degree of quality. To make sound and logical decisions and to choose the appropriate courses of action based on the parameters of the situation at hand and to use continual improvement problem solving skills.
• Assist in the creation of an ongoing effort to improve the Company and the Manufacturing Department through personal action and by contributing ideas to support both the Department and Company’s ongoing improvement efforts.
• Understand Mizuho OSI’s business objectives and the relationship between the Manufacturing Department and those objectives; to support and follow the Corporate Vision, Mission & Values Statements and to maintain the services and quality levels set by Mizuho OSI.
• Understand, follow and support Mizuho OSI’s internal Quality System policies, procedures and instructions, including, but not limited to, applicable external regulations (21 Code of Federal Regulations Part 820 Quality System Regulations and applicable International Standards).

Qualifications & Requirements:

• Bachelor's Degree in Mechanical, Electrical, Industrial, or Biomedical Engineering & 0 -2  years of experience.
• 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. Ability to efficiently and effectively use Microsoft products such as Outlook, Word, Excel, Project, Visio and PowerPoint to analyze data, produce trend charts and presentations.
• Fluency in English with excellent verbal and written communication skills.
• Ability to communicate effectively with employees and other business contacts in 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 in a fast-paced environment managing multiple priorities simultaneously.
• Able to manage situations of a dynamic nature; to modify plans, actions, and decisions considering changing situations and circumstances while still meeting, or proposing modified, deadlines.
•  The ability to present strong problem-solving skills and to analyze data, conduct process analysis, and use tools like control and Pareto charts.
• Ability to perform basic statistical analysis, create and reconcile reports, demonstrate strong analytical skills, with attention to detail.
• Goal driven independent thinker, equally capable as an individual contributor or project team leader; is data driven and promotes willingness to adopt new methods, procedures, and techniques for organizational and cultural change.
• Experience in medical device manufacturing environment preferred (ISO 13485, 21 CFR 820)

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

Pay Scale: $74,000- $85,000 DOE + potential annual bonus + comprehensive benefits package