Sr. Manager, Quality Assurance 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 Senior Manager, Quality Assurance Engineer (QAE), reporting to the Senior Director of Quality Assurance and Regulatory Affairs, supports the development efforts of Mizuho OSI’s position on medical device quality assurance and regulatory policies. This position provides guidance and leadership for the Quality Department including Quality Control Inspection, Document Control and Quality Assurance Engineering. This individual assigns and monitors the work, provides training and development to the staff and is responsible for adhering to the department’s budget.

This position is also responsible for planning resources and staffing appropriately. The Senior QAE Manager provides the Senior Director feedback on department-related issues, including those with company-wide or external impact.

The Senior Manager effectively participates in cross-functional teams for new product launches and supports strategic/long-term quality development and company wide compliance plans and the implementation of such policies (internal and external). The Senior QAE Manager supervises the Quality Assurance Engineering group.

Responsibilities:

Mentor, train and provide technical support to the Quality Assurance Engineering Group.

Provide frequent and timely verbal feedback to team members, as well as document their performance in the annual Focal Review performance evaluation process.

Administer and enforce company policies. Manage employee performance and assist in career development following a process to ensure fairness and proper communication as needed.

Provide guidance and leadership to the Quality Assurance Engineering group; manage resources to support schedules, priorities and customer.

Coordinate and support the internal audit program, providing quality assurance and compliance activities that are in accordance with current domestic and international requirements.

Participate in and/or manage the internal quality auditing system including planning, reporting and development of audit schedules.

Participate in and/or manages external regulatory audits/inspections including in developing corrective action plans for audit outcomes. Drives preventive actions to ensure compliance and audit ready state at all times. Participate in and/or manage corrective and preventative action processes for both internal and external suppliers, including service providers.

Participate in Material Review Board (MRB) activities.

Participate in the development and implementation of new procedures for quality systems (ISO and QSR), consistent with Mizuho OSI policies and procedures, including local, state, federal and international regulations.

Provide direct assistance on design projects for new product introduction ensuring advanced compliance with internal and external quality requirements.

Maintain existing Quality System; generate reports of trend analysis and statistical distribution for manufacturing process audits and product audits.

Implement change and review current processes throughout the organization to enhance overall performance. Responsible for supporting review sterilization validation processes as well as release of Sterile products Participate as an interface and coordinator between departments to assure harmonization of Quality System documentation.

Work closely with and serve as a liaison to members of other functional teams throughout the organization, being a key resource and…